Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

Completed · Phase 2

Conditions studied: Hemophilia A

In brief

This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.

Key facts

Study ID

NCT00989196

Run by

Octapharma

People needed

22

Starts

2010-05-01

Expected to finish

2012-09-01

Last updated by the study team

2019-10-08

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Severe hemophilia A (FVIII:C <= 1%)
• Male subjects between 12 and 65 years of age
• Body weight 25 kg to 110 kg
• Previously treated with FVIII concentrate for at least 150 EDs

You may not qualify if…

• Other coagulation disorder than hemophilia A
• Present or past FVIII inhibitor activity

Where it is running

• UCLA Orthodpedic Hospital — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• University of Colorado — Denver, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• RUSH University Medical Center — Chicago, Illinois, United States
• University of Medicine and Dentistry — New Brunswick, New Jersey, United States
• Prof. Lissitchkov — Sofia, Bulgaria
• Medizinische Hochschule — Hanover, Lower Saxony, Germany
• Vivantes Klinikum — Berlin, Germany

Full record on ClinicalTrials.gov

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