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

Severe Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027377
• Other study ID #: 998HA101
• Status: Completed
• Phase: Phase 1
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: August 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A
• Severe Hemophilia A

Intervention

Drug:
• rFVIIIFc
Single dose
• rFVIIIFc
Single dose

Locations

Country	Name	City	State
Hong Kong	Research Site	Hong Kong
Israel	Research Site	Tel Aviv
United States	Research Site	Los Angeles	California
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Sacramento	California
United States	Research Site	Seattle	Washington
United States	Research Site	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bioverativ Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Hong Kong,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be assessed by physical examination, vital signs, laboratory changes overtime, adverse events, and assessment of inhibitor (Bethesda) and antibody development against rFVIIIFc.		78 weeks
Secondary	Pharmacokinetic parameters will be measured such as, but not limited to Tmax, Cmax, t1/2, CL, Vd, AUC, MRT, and incremental recovery.		78 weeks
Secondary	To determine the pharmacokinetics parameters after single administration of 25 and 65 IU/kg of rFVIIFc compared to advate		78 weeks
Secondary	To determine the pharmacodynamic activity of FVIII over time for both doses of rFVIIIFc		78 weeks