Brief Title
Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A
Official Title
An Open-Label, Crossover, Dose-Escalation, and Multi-Center Study to Determine the Safety, Tolerability, and Pharmacokinetic of a Single Intravenous Injection of rFVIIIFc in Previously Treated Patients With Severe Hemophilia A
Brief Summary
The study is to investigate the safety, tolerability, and pharmacokinetics (the determination
of the concentration of the administered drug in blood over time) of recombinant Factor VIII
Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Safety will be assessed by physical examination, vital signs, laboratory changes overtime, adverse events, and assessment of inhibitor (Bethesda) and antibody development against rFVIIIFc.
Secondary Outcome
Pharmacokinetic parameters will be measured such as, but not limited to Tmax, Cmax, t1/2, CL, Vd, AUC, MRT, and incremental recovery.
Condition
Severe Hemophilia A
Intervention
rFVIIIFc
Study Arms / Comparison Groups
A
Description: Cohort to receive a single low dose intravenous injection of commercially available rFVIII with safety and PK assessments followed by a single low dose intravenous injection of rFVIIIFc with safety and PK assessments
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
December 2009
Completion Date
May 2011
Primary Completion Date
July 2010
Eligibility Criteria
Inclusion Criteria:
1. Male and 12 years of age and older and weigh at least 40 kg
2. Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%)
3. History of at least 100 exposure days to any Factor VIII product
Exclusion Criteria:
1. History of Factor VIII inhibitors
2. Kidney or liver dysfunction
3. Diagnosed with another coagulation defect other than hemophilia A
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT01027377
Organization ID
998HA101
Responsible Party
Sponsor
Study Sponsor
Bioverativ Therapeutics Inc.
Study Sponsor
, ,
Verification Date
August 2018