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

Bioverativ Therapeutics Inc.16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Hemophilia A

Interventions

rFVIIIFcDRUG

Single dose

rFVIIIFcDRUG

Single dose

Eligibility

Sex: MALEMin age: 12 Years

Medical Language ↔ Plain English

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)

Research Site

Los Angeles, California, United States

Research Site

Sacramento, California, United States

Research Site

Waltham, Massachusetts, United States

Research Site

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Safety will be assessed by physical examination, vital signs, laboratory changes overtime, adverse events, and assessment of inhibitor (Bethesda) and antibody development against rFVIIIFc.

Time frame: 78 weeks

Secondary Outcomes

Pharmacokinetic parameters will be measured such as, but not limited to Tmax, Cmax, t1/2, CL, Vd, AUC, MRT, and incremental recovery.

Time frame: 78 weeks

To determine the pharmacokinetics parameters after single administration of 25 and 65 IU/kg of rFVIIFc compared to advate

Time frame: 78 weeks

To determine the pharmacodynamic activity of FVIII over time for both doses of rFVIIIFc

Time frame: 78 weeks

Data from ClinicalTrials.gov

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