NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

CompletedPhase 1

Sponsor: Bioverativ Therapeutics Inc.

Conditions: Severe Hemophilia A

Interventions: rFVIIIFc, rFVIIIFc

Countries: United States, Hong Kong, Israel

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.

Eligibility overview

Sex: MALE

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (7)

Los Angeles, California, United States
Sacramento, California, United States
Waltham, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Hong Kong, Hong Kong
Tel Aviv, Israel