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| Name | Class |
|---|---|
| Baxalta Innovations GmbH, now part of Shire | INDUSTRY |
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The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.
This study will comprise of Part 1 and Part 2. Each study part will consist of three treatment arms (Part 1 [approximately 24 participants]: Treatment Arms 1-3 and Part 2 [approximately 24 participants]: Treatment Arms 4-6). Treatment arms will be initiated in parallel within each study part. Each participant will participate in only one treatment arm. After participants in Treatment Arms 1-3 (Study Part 1) will complete Week 9, the tolerability and, safety data through Week 9 will be reviewed by a safety review team. (Participants in arms 1-3 will continue in the study as the safety review is being completed.) Once the safety review for Arms 1-3 (Study part 1) will be completed and approved, Treatment Arms 4-6 (Study Part 2) will begin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Schedule A: TA 1 (Low TDL HYQVIA) | Experimental | Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
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| Part 2 Schedule A: TA 4 (High TDL HYQVIA) | Experimental | Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
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| Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Experimental | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
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| Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Experimental | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
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| Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYQVIA | Drug | Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Tolerated All Initiated HYQVIA Infusion | A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to an adverse event (AE) related to HYQVIA infusion. Tolerability was measured in terms of the number of participants for which the infusions was tolerable. Number of participants who tolerated all initiated HYQVIA Infusion were reported. | From start of the study drug administration up to Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAE) were defined as any event not present prior to the initiation of the treatments or any event already present that worsened in either intensity or frequency following exposure to the treatments. Number of participants with TEAEs was reported. | From start of the study drug administration up to Week 25 |
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Inclusion Criteria:
Exclusion Criteria:
Any current or relevant history of medical (e.g. any hematological, hepatic, respiratory, cardiovascular, renal or neurological) or psychiatric conditions, which by judgment of the investigator might compromise the safety of the participant or integrity of the study, interfere with the participant's participations in the trial and compromise the trial objectives or any condition that presents undue risk from the investigational product or procedures Note: Participants on stable dose of hormone replacements (i.e. thyroid hormone replacement) or oral contraceptives are permitted
Clinically significant cardiac conditions including but not limited to uncontrolled hypertension, myocardial infarction, unstable coronary artery disease and clinically significant arrhythmias and conduction disorders
Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients (e.g. human IG, hyaluronidase, albumin)
Known history of hypersensitivity or severe allergic reactions (e.g. urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following administration of blood or blood components
Significant illness, as judged by the investigator, within 30 days of the first dose of investigational product
Known history of alcohol or other substance abuse within the last year
Donation of blood within 60 days, or blood products (e.g., plasma or platelets) within 2 weeks prior receiving the first dose of investigational product
Participants will be excluded if any of the following laboratory parameters meet the criteria below:
Hemoglobin less than (<) 11 gram per deciliter (g/dL). Absolute neutrophil count less than or equal to (< or =) 1500/ cubic millimeter (mm^3) and platelet count less than or equal to (< or =) 100,000/mm^3 Liver function: alanine aminotransferase (ALT) greater than or equal to > or =2.5 × upper limit normal (ULN), aspartate aminotransferase (AST) > or =2.5 × upper limit normal (ULN), alkaline phosphatase > or =1.5 × ULN or total bilirubin > or =1.5 milligram per deciliter (mg/dL) Renal function: creatinine clearance <or= 60 milliliter per minute (mL/min) based on Cockcroft-Gault equation Coagulation tests: activated partial thromboplastin time (aPTT) >1.2 X ULN; international normalized ratio (INR) >1.2 Participants will be excluded if any other laboratory values are outside the reference range and are clinically significant per investigator's judgment.
Within 30 days prior to the first dose of investigational product:
Confirmed systolic blood pressure >139 mmHg or <89 mmHg and diastolic blood pressure >89 mmHg or <49 millimeters of Mercury (mmHg)
A positive screen for alcohol or drugs of abuse at screening or D-1
A positive human immunodeficiency virus (HIV), hepatitis C virus (HCV), or ongoing/active hepatitis B infection at screening. Participants with immunity to hepatitis B from either active vaccination or from previous natural infection are eligible to participate in the study.
Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during confinement in the CRU
Severe dermatitis or anatomical abnormality that would interfere with HYQVIA administration or endpoint assessments Note: the skin at the administration site should not be covered by tattoos.
Current use of any herbal, or homeopathic preparations are not permitted
Unable or unwilling to discontinue antihistamines or medications with antihistamine properties, sedatives, anxiolytics, systemic steroids, or topical steroids or antibiotics on any area below the chest for a minimum of 48 hours prior to each infusion visit and through 72 hours post last infusion
Current or relevant history of hypercoagulable conditions (e.g. Protein C, Protein S, and antithrombin III deficiency), thrombotic/thromboembolic events or venous thrombosis
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc | Hialeah | Florida | 33014 | United States |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
This study was conducted in 2 parts with a target dose level (TDL) of either 0.4 grams/kilograms (g/kg) (Part 1) or 1.0 g/kg (Part 2) through dose Ramp-Up or No Ramp-Up (direct administration of TDL). Each study part consisted of 3 TA (Part 1: TA 1 to 3 and Part 2: TA 4 to 6. TA 1 and 4 followed Schedule A (1/4 of the TDL to the full TDL) and TA 2 and 5 followed Schedule B (1/2 of TDL to full TDL) and TA 3 and 6 followed no ramp up (Schedule C).
A total of 51 participants were enrolled in the study, 33 participants into the Ramp-Up dosing group (treatment arms [TA] 1, 2, 4, and 5) and 18 participants into the No Ramp-Up dosing group (TA 3 and TA 6).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Schedule A: TA 1 (Low TDL HYQVIA) | Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
| FG001 | Part 2 Schedule A: TA 4 (High TDL HYQVIA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2020 | Feb 27, 2023 |
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Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
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| Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Experimental | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
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| HYQVIA | Drug | Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
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| HYQVIA | Drug | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
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| HYQVIA | Drug | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
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| HYQVIA | Drug | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
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| HYQVIA | Drug | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
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| Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20) | Binding antibodies are responsible for binding to a pathogen and alerting the immune system to its presence so white blood cells can be sent to destroy it. The antibody level (titer) in the blood tells health care provider whether or not participant been exposed to an antigen, or something that the body thinks is foreign. A neutralizing antibody (NAb) is an antibody that is responsible for defending cells from pathogens, which are organisms that cause disease. The number of participants who developed binding and neutralizing antibodies to rHuPH20 were reported. | From start of the study drug administration up to Week 25 |
| Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Tmax was a measure of the time to reach the maximum concentration in the plasma after the drug dose. Summarized baseline corrected data was reported. | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
| Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Cmax was a measure of the maximum amount of drug in the serum after the dose is given. Summarized baseline corrected data was reported. | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
| Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Summarized baseline corrected data was reported. | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
| Terminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | T1/2 was the time required for a given drug concentration in the plasma to decrease by 50%. Summarized baseline corrected data was reported. | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
| Apparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Apparent clearance was a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Summarized baseline corrected data was reported. | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
| Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Volume of distribution (Vz/F) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Summarized baseline corrected data was reported. | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
| FG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| FG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| FG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| FG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
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The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Schedule A: TA 1 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
| BG001 | Part 2 Schedule A: TA 4 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
| BG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| BG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| BG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| BG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Tolerated All Initiated HYQVIA Infusion | A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to an adverse event (AE) related to HYQVIA infusion. Tolerability was measured in terms of the number of participants for which the infusions was tolerable. Number of participants who tolerated all initiated HYQVIA Infusion were reported. | The safety set included all enrolled participants who received at least 1 dose of HYQVIA. | Posted | Count of Participants | Participants | From start of the study drug administration up to Week 9 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAE) were defined as any event not present prior to the initiation of the treatments or any event already present that worsened in either intensity or frequency following exposure to the treatments. Number of participants with TEAEs was reported. | The safety set included all enrolled participants who received at least 1 dose of HYQVIA. | Posted | Count of Participants | Participants | From start of the study drug administration up to Week 25 |
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| Secondary | Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20) | Binding antibodies are responsible for binding to a pathogen and alerting the immune system to its presence so white blood cells can be sent to destroy it. The antibody level (titer) in the blood tells health care provider whether or not participant been exposed to an antigen, or something that the body thinks is foreign. A neutralizing antibody (NAb) is an antibody that is responsible for defending cells from pathogens, which are organisms that cause disease. The number of participants who developed binding and neutralizing antibodies to rHuPH20 were reported. | The safety set included all enrolled participants who received at least 1 dose of HYQVIA. | Posted | Count of Participants | Participants | From start of the study drug administration up to Week 25 |
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| Secondary | Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Tmax was a measure of the time to reach the maximum concentration in the plasma after the drug dose. Summarized baseline corrected data was reported. | PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories. | Posted | Median | Full Range | days | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
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| Secondary | Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Cmax was a measure of the maximum amount of drug in the serum after the dose is given. Summarized baseline corrected data was reported. | PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories. | Posted | Geometric Mean | Geometric Coefficient of Variation | grams per liter (g/L) | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
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| Secondary | Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Summarized baseline corrected data was reported. | PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*gram per liter (day*g/L) | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
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| Secondary | Terminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | T1/2 was the time required for a given drug concentration in the plasma to decrease by 50%. Summarized baseline corrected data was reported. | PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories. "0" in analyzed field signifies that none of the participants had evaluable data at specified timepoint. | Posted | Median | Full Range | days | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
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| Secondary | Apparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Apparent clearance was a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Summarized baseline corrected data was reported. | PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "0" in analyzed field signifies that none of the participants had evaluable data at specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per day per kilograms (L/day/kg) | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
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| Secondary | Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4) | Volume of distribution (Vz/F) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Summarized baseline corrected data was reported. | PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "0" in analyzed field signifies that none of the participants had evaluable data at specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per kilogram (L/Kg) | Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6 |
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From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 Schedule A: TA 1 (Low TDL HYQVIA) | Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG001 | Part 2 Schedule A: TA 4 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner, | 0 | 10 | 0 | 10 | 10 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure systolic decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Infusion site extravasation | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Infusion site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2022 | Feb 27, 2023 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
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| OG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
|
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| OG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
|
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| OG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
|
|
| OG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
|
|
| OG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
|
|
| OG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on days 1 and 15, followed by 1.0 g/kg (full TDL) at days 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
|
|
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. |
| OG002 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG003 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. |
| OG004 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. |
| OG005 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner, |
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