| Primary | Area Under the Curve | Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method | Number of complete crossover participants (per protocol) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI. | Posted | | Geometric Mean | Standard Deviation | IU*h/dL | | Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion | | | | ID | Title | Description |
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| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001257.20± 380.60
- OG0011297.42± 487.57
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| | 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 |
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| | | | | | Difference of Least-Squares Means | -0.052 | | | | 90 | -0.117 | 0.012 | | | | | Non-Inferiority or Equivalence (legacy) | Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001. | |
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| Secondary | Total Area Under the Curve | Total AUC when the concentration is extrapolated to zero using the slope of the β-phase of the model | Number of complete crossover participants (intent to treat) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI. | Posted | | Geometric Mean | Standard Deviation | IU*h/dL | | Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Adjusted in Vivo Incremental Recovery | Increase in factor VIII concentration from pre- to post-infusion | | Posted | | Geometric Mean | Standard Deviation | IU/dL:IU/kg | | Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI | | OG002 | Pediatrics - 2 mL | Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG003 | Pediatrics - 5 mL | Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Terminal Half-life | Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%. | | Posted | | Mean | Standard Deviation | hours | | Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Weight-Adjusted Clearance | Computed as the weight-adjusted dose divided by total AUC | | Posted | | Mean | Standard Deviation | mL/(kg*h) | | Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Mean Residence Time | Computed as total area under the moment curve divided by the total AUC. Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods | | Posted | | Mean | Standard Deviation | hours (h) | | Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Volume of Distribution at Steady State | Computed as weight-adjusted clearance * mean residence time | | Posted | | Mean | Standard Deviation | dL/kg | | Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Maximum Plasma Concentration | Maximal factor VIII concentration post-infusion | | Posted | | Geometric Mean | Standard Deviation | IU/dL | | Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Number and Severity of Infusion Site Reactions | Infusion-related local reactions (including pain, tenderness, erythema, induration, and bruising) and severity were evaluated according to an FDA-defined grading scale (FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; 2007). | Participants who received at least 1 infusion | Posted | | Number | | Participants | | Within 5 minutes pre-infusion up to 24 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI | | OG002 | Pediatrics - 2 mL | Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG003 | Pediatrics - 5 mL | Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI |
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| Secondary | Infusion Site Pain | Pain was assessed by participants (≥5 years of age) on a visual analog scale (VAS) from 0 (no pain) to 100 (worst possible pain). | Participants who received at least 1 infusion | Posted | | Median | Full Range | Scores on a scale | | Within 5 minutes post-infusion up to 24 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Adolescents/Adults - 2 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI | | OG001 | Adolescents/Adults - 5 mL | Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=26) | | OG002 | Pediatrics at Least 5 Years of Age - 2 mL | Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI (note: 6 hours after infusion n=7) | | OG003 | Pediatrics at Least 5 Years of Age - 5 mL | Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=7) |
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