Back to resultsPharmacokinetics of rFVIIIFc at Two Vial Strengths
Primary Purpose
Severe Hemophilia A
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
rFVIIIFc
Sponsored by
About this trial
This is an interventional treatment trial for Severe Hemophilia A
Eligibility Criteria
Key Inclusion Criteria:
- Have severe hemophilia A
- Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
- No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not exclude subjects.
- No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at Screening.
- Platelet count ≥100,000 platelets/μL at screening
- CD4 lymphocytes >200 mm3 if known as HIV antibody positive at screening.
- Viral load of <400 copies/mL if known HIV antibody positive at screening.
Key Exclusion Criteria:
- Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion.
- Previous treatment with rFVIIIFc as study drug or commercial product.
- Other coagulation disorder(s) in addition to hemophilia A.
- History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration.
- Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted).
- Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids.
NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
rFVIIIFc 1000 / 3000 PK Assessment
rFVIIIFc 3000 / 1000 PK Assessment
Arm Description
A single intravenous (IV) injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial followed by a single IV injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial. Following the PK assessment, participants will receive either an episodic (on-demand) regimen with doses between 20 and 50 IU/kg based on the severity of the bleeding episode, or 1 of 2 prophylactic regimens: 50 IU/kg every 3 to 5 days or 65 IU/kg weekly. Participants will be allowed to switch from one regimen to another if approved by the Investigator.
A single IV injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial followed by a single IV injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial. Following the PK assessment, participants will receive either an episodic (on-demand) regimen with doses between 20 and 50 IU/kg based on the severity of the bleeding episode, or 1 of 2 prophylactic regimens: 50 IU/kg every 3 to 5 days or 65 IU/kg weekly. Participants will be allowed to switch from one regimen to another if approved by the Investigator.
Outcomes
Primary Outcome Measures
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by Activated Partial Thromboplastin Time (aPTT) Clotting Assay
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Incremental Recovery (IR, K Value) as Estimated From the FVIII Activity Data Measured by aPTT Clotting Assay
The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.
Secondary Outcome Measures
Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay
Maximum measured concentration of rFVIIIFc.
Half-life (t½) as Measured by aPTT Clotting Assay
Time required for the concentration of the drug to reach half of its original value.
Clearance (CL) as Measured by the aPTT Clotting Assay
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.
Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay
The apparent volume of distribution at steady state. (Volume of distribution 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.)
Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay
The average time at which the number of absorbed molecules reside in the body, after single-dose administration.
Time of Cmax (Tmax) as Measured by aPTT Clotting Assay
Time at which maximum activity (Cmax) is observed.
Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay
Area under the plasma concentration time-curve from zero to the last measured concentration.
Terminal Exponential Rate Constant (Lambda Z) as Measured by aPTT Clotting Assay
First order rate constant associated with the terminal portion of the curve (lambda z) .
Percentage of AUCinf From the Last Data Point to Infinity (AUCext) as Measured by aPTT Clotting Assay
Percentage of AUCinf extrapolated from the last data point to infinity.
Dose Normalized Area Under the Curve (DNAUC) as Measured by aPTT Clotting Assay
Dose normalized area under the FVIII activity-time curve.
Terminal Exponential Volume of Distribution (Vz) as Measured by aPTT
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.
AUCinf as Estimated From the FVIII Activity Data as Measured by Two-Stage Chromogenic Clotting Assay
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
IR, K Value as Measured by Two-Stage Chromogenic Clotting Assay
The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.
Cmax as Measured by Two-Stage Chromogenic Clotting Assay
Maximum measured concentration of rFVIIIFc.
t½ as Measured by Two-Stage Chromogenic Clotting Assay
Time required for the concentration of the drug to reach half of its original value.
CL as Measured by Two-Stage Chromogenic Clotting Assay
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.
Vss as Measured by Two-Stage Chromogenic Clotting Assay
The apparent volume of distribution at steady state. (Volume of distribution 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.)
MRT as Measured by Two-Stage Chromogenic Clotting Assay
The average time at which the number of absorbed molecules reside in the body, after single-dose administration.
Tmax as Measured by Two-Stage Chromogenic Clotting Assay
Time at which maximum activity (Cmax) is observed.
AUClast as Measured by Two-Stage Chromogenic Clotting Assay
Area under the plasma concentration time-curve from zero to the last measured concentration.
Lambda Z as Measured by Two-Stage Chromogenic Clotting Assay
First order rate constant associated with the terminal portion of the curve (lambda z).
AUCext as Measured by Two-Stage Chromogenic Clotting Assay
Percentage of AUCinf extrapolated from the last data point to infinity.
DNAUC as Measured by Two-Stage Chromogenic Clotting Assay
Dose normalized area under the FVIII activity-time curve.
Vz as Measured by Two-Stage Chromogenic Clotting Assay
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.
Development of Inhibitor as Measured by the Nijmegen-Modified Bethesda Assay
An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the proportion of subjects 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.
Full Information
NCT ID
NCT02083965
First Posted
March 7, 2014
Last Updated
December 16, 2020
Sponsor
Bioverativ Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02083965
Brief Title
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
Official Title
A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetics of 2 Vial Strengths of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in Previously Treated Subjects With Severe Hemophilia A
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioverativ Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.
Detailed Description
This is a randomized, open-label, crossover study during which each participant receives a single injection of rFVIIIFc from 2 different vial concentrations (PK assessment). After the PK assessment, participants are provided with rFVIIIFc for either prophylactic or episodic (on-demand) treatment for up to 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hemophilia A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rFVIIIFc 1000 / 3000 PK Assessment
Arm Type
Experimental
Arm Description
A single intravenous (IV) injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial followed by a single IV injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial.
Following the PK assessment, participants will receive either an episodic (on-demand) regimen with doses between 20 and 50 IU/kg based on the severity of the bleeding episode, or 1 of 2 prophylactic regimens: 50 IU/kg every 3 to 5 days or 65 IU/kg weekly. Participants will be allowed to switch from one regimen to another if approved by the Investigator.
Arm Title
rFVIIIFc 3000 / 1000 PK Assessment
Arm Type
Experimental
Arm Description
A single IV injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial followed by a single IV injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial.
Following the PK assessment, participants will receive either an episodic (on-demand) regimen with doses between 20 and 50 IU/kg based on the severity of the bleeding episode, or 1 of 2 prophylactic regimens: 50 IU/kg every 3 to 5 days or 65 IU/kg weekly. Participants will be allowed to switch from one regimen to another if approved by the Investigator.
Intervention Type
Biological
Intervention Name(s)
rFVIIIFc
Other Intervention Name(s)
Eloctate, antihemophilic factor [recombinant] FC fusion protein, recombinant coagulation factor VIII Fc fusion protein, efmoroctocog alfa, BIIB031, Elocta
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by Activated Partial Thromboplastin Time (aPTT) Clotting Assay
Description
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Incremental Recovery (IR, K Value) as Estimated From the FVIII Activity Data Measured by aPTT Clotting Assay
Description
The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Secondary Outcome Measure Information:
Title
Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay
Description
Maximum measured concentration of rFVIIIFc.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Half-life (t½) as Measured by aPTT Clotting Assay
Description
Time required for the concentration of the drug to reach half of its original value.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Clearance (CL) as Measured by the aPTT Clotting Assay
Description
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay
Description
The apparent volume of distribution at steady state. (Volume of distribution 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.)
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay
Description
The average time at which the number of absorbed molecules reside in the body, after single-dose administration.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Time of Cmax (Tmax) as Measured by aPTT Clotting Assay
Description
Time at which maximum activity (Cmax) is observed.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay
Description
Area under the plasma concentration time-curve from zero to the last measured concentration.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Terminal Exponential Rate Constant (Lambda Z) as Measured by aPTT Clotting Assay
Description
First order rate constant associated with the terminal portion of the curve (lambda z) .
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Percentage of AUCinf From the Last Data Point to Infinity (AUCext) as Measured by aPTT Clotting Assay
Description
Percentage of AUCinf extrapolated from the last data point to infinity.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Dose Normalized Area Under the Curve (DNAUC) as Measured by aPTT Clotting Assay
Description
Dose normalized area under the FVIII activity-time curve.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Terminal Exponential Volume of Distribution (Vz) as Measured by aPTT
Description
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.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
AUCinf as Estimated From the FVIII Activity Data as Measured by Two-Stage Chromogenic Clotting Assay
Description
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
IR, K Value as Measured by Two-Stage Chromogenic Clotting Assay
Description
The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Cmax as Measured by Two-Stage Chromogenic Clotting Assay
Description
Maximum measured concentration of rFVIIIFc.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
t½ as Measured by Two-Stage Chromogenic Clotting Assay
Description
Time required for the concentration of the drug to reach half of its original value.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
CL as Measured by Two-Stage Chromogenic Clotting Assay
Description
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Vss as Measured by Two-Stage Chromogenic Clotting Assay
Description
The apparent volume of distribution at steady state. (Volume of distribution 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.)
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
MRT as Measured by Two-Stage Chromogenic Clotting Assay
Description
The average time at which the number of absorbed molecules reside in the body, after single-dose administration.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Tmax as Measured by Two-Stage Chromogenic Clotting Assay
Description
Time at which maximum activity (Cmax) is observed.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
AUClast as Measured by Two-Stage Chromogenic Clotting Assay
Description
Area under the plasma concentration time-curve from zero to the last measured concentration.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Lambda Z as Measured by Two-Stage Chromogenic Clotting Assay
Description
First order rate constant associated with the terminal portion of the curve (lambda z).
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
AUCext as Measured by Two-Stage Chromogenic Clotting Assay
Description
Percentage of AUCinf extrapolated from the last data point to infinity.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
DNAUC as Measured by Two-Stage Chromogenic Clotting Assay
Description
Dose normalized area under the FVIII activity-time curve.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Vz as Measured by Two-Stage Chromogenic Clotting Assay
Description
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.
Time Frame
Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection
Title
Development of Inhibitor as Measured by the Nijmegen-Modified Bethesda Assay
Description
An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the proportion of subjects 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.
Time Frame
Predose, Month 3, Month 6/early withdrawal. Additionally: If inhibitor suspected; at 10-15 EDs; 2-4 weeks prior to scheduled surgery; preoperatively on day of surgery; 1-2 weeks post-surgery; at last postoperative visit (last 2 for major surgery only)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Have severe hemophilia A
Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not exclude subjects.
No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at Screening.
Platelet count ≥100,000 platelets/μL at screening
CD4 lymphocytes >200 mm3 if known as HIV antibody positive at screening.
Viral load of <400 copies/mL if known HIV antibody positive at screening.
Key Exclusion Criteria:
Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion.
Previous treatment with rFVIIIFc as study drug or commercial product.
Other coagulation disorder(s) in addition to hemophilia A.
History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration.
Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted).
Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids.
NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Bioverativ Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Herston
Country
Australia
Facility Name
Research Site
City
Perth
Country
Australia
Facility Name
Research Site
City
Basingstoke
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
We'll reach out to this number within 24 hrs