| Primary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage Activated Partial Thromboplastin Time (aPTT) Clotting Assay for Pharmacokinetic Assessment 1 (PK1) and Pharmacokinetic Assessment 2 (PK2) | AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The Pharmacokinetic Analysis Set (PKAS) included all participants who have evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 90% Confidence Interval | International unit*hour per deciliter | | Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). . | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for pharmacokinetic assessment 2 (PK2). Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at Pharmacokinetic assessment 3 (PK3) at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002255.6(1886.2 to 2697.4)
- OG0012425.8(2084.2 to 2823.4)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Adjusted Geometric Mean Ratio | 1.08 | | | 2-Sided | 90 | 0.93 | 1.24 | | | The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1). | | Other | | |
|
| Primary | Incremental Recovery (IR) as Measured by One-stage aPTT Clotting Assay for PK1 and PK2 | Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS included all participants who have evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 90% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2 | Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | International units per deciliter (IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2 | Half-life is time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2 | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | milliliter per hour per kilogram(mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2 | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | milliliter per kilogram (mL/kg) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | |
|
| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2 | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK2 and PK3 | AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | IU*h/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | |
|
| Secondary | Incremental Recovery (IR) as Measured by One-stage aPTT Clotting Assay for PK2 and PK3 | Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
|
| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3 | Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
|
| Secondary | Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3 | Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | |
|
| Secondary | Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3 | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | |
|
| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3 | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3 | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | AUCinf is area under the concentration-time curve from time zero to infinity. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU*h/dL | | Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Incremental Recovery (IR) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg). | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Cmax is defined as maximum activity of rFVIIIFc. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Time required for the concentration of the drug to reach half of its original value. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | |
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| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | AUCinf is area under the concentration-time curve from time zero to infinity. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | IU*h/dL | | Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
| |
| Secondary | Incremental Recovery (IR) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg). | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
| |
| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Cmax is defined as maximum activity of rFVIIIFc. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
| |
| Secondary | Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Time required for the concentration of the drug to reach half of its original value. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
| |
| Secondary | Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
| |
| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK1 and PK2 | AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | IU*h/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Incremental Recovery (IR) as Measured by the Two-stage Chromogenic Assay for PK1 and PK2 | Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2 | Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2 | Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2 | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
|
| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2 | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | |
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| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2 | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2). | The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 2K rFVIIIFc (1000 IU/Vial Strength) (PK1) | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1). | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK2 and PK3 | AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | IU*h/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | |
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| Secondary | Incremental Recovery (IR) as Measured by the Two-stage Chromogenic Assay for PK2 and PK3 | Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3 | Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3 | Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3) | |
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| Secondary | Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3 | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | |
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| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured the Two-stage Chromogenic Assay for PK2 and PK3 | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3 | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | AUCinf is area under the concentration-time curve from time zero to infinity. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU*h/dL | | Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Incremental Recovery (IR) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg). | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Cmax is defined as maximum activity of rFVIIIFc. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Time required for the concentration of the drug to reach half of its original value. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK2) | |
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| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial) | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK2) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. | |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | AUCinf is area under the concentration-time curve from time zero to infinity. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | IU*h/dL | | Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Incremental Recovery (IR) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg). | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL per IU/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
|---|
| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Cmax is defined as maximum activity of rFVIIIFc. | The PKAS is defined as all participants with evaluable PK profiles. | Posted | | Geometric Mean | 95% Confidence Interval | IU/dL | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Time required for the concentration of the drug to reach half of its original value. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | Hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | milliliter per hour per kilogram(mL/h/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | mL/kg | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial) | The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | The PKAS is defined as all participants with evaluable PK profiles. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | hours (h) | | Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. | | OG001 | 15K rFVIIIFc (6000 IU/Vial Strength) (PK3) | Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength. |
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| Secondary | Development of Inhibitors as Measured by the Nijmegen-modified Bethesda Assay | An inhibitor test result greater than or equal to (>=)0.6 Bethesda units [BU]/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. The test was performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the percentage of participants with a confirmed inhibitor was calculated using the Clopper-Pearson method for a binomial proportion. Percentage of participants with confirmed inhibitor development was summarized overall. | The population analyzed included all participants who received at least 1 dose of rFVIIIFc. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At screening and predose on Day 1, 13 and 26 weeks after PK2 injection or at Early Termination (Approximately 43 weeks) | | | | ID | Title | Description |
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| OG000 | 2K/15K rFVIIIFc (1000/6000 IU/Vial Strength)- All Participants | All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for PK1. At PK1, participants were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) at 15K Manufacturing Scale | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of Participants with TEAEs were summarized overall. | The population analyzed included all participants who received at least 1 dose of rFVIIIFc at 15k manufacturing scale. | Posted | | Count of Participants | | Participants | | Approximately 43 weeks | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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| Secondary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) at 15K Manufacturing Scale | An SAE is any untoward medical occurrence that at any dose: results in death or in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. All major surgeries will be reported as SAEs. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the SAE definition. Number of participants with TESAEs were summarized overall. | The population analyzed included all participants who received at least 1 dose of rFVIIIFc at 15k manufacturing scale. | Posted | | Count of Participants | | Participants | | Approximately 43 weeks | | | | ID | Title | Description |
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| OG000 | 15K rFVIIIFc (1000 and 6000 IU/Vial Strength) | Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment. |
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