Status:
COMPLETED
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
Lead Sponsor:
Octapharma
Conditions:
Hemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE2
Brief Summary
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 previo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Other coagulation disorder than hemophilia A
- Present or past FVIII inhibitor activity
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00989196
Start Date
May 1 2010
End Date
September 1 2012
Last Update
October 8 2019
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Orthodpedic Hospital
Los Angeles, California, United States, 90007
2
University of California, Davis
Sacramento, California, United States, 95817
3
University of Colorado
Denver, Colorado, United States, 80045
4
Georgetown University
Washington D.C., District of Columbia, United States, 20057