Status:
COMPLETED
Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.
Lead Sponsor:
Recoly N.V.
Conditions:
Haemophilia A
Eligibility:
MALE
18-60 years
Phase:
PHASE2
Brief Summary
Primary efficacy endpoint: To study whether there is a difference in the length of the bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2 mg of pegylated lip...
Detailed Description
Each subject will receive treatment for three bleeding episodes ("wash-in", on demand injections) followed by a minimum 4 day wash-out. Following this each subject will be randomized to a specific tre...
Eligibility Criteria
Inclusion
- Between 18 and 60 years of age
- Severe haemophilia A (≤ 1% of baseline Factor VIII activity)
- At least 250 treatment cumulative exposure-days (CEDs) to previous products
- At least 25 cumulative exposure-days (CEDs) to previous products during one year prior to study start
- If HIV positive, CD4 lymphocytes ≥ 400/µl
- Subjects on demand treatment, and with a minimum bleeding/treatment pattern of a four episodes per month, evenly distributed within each month, during the three month preceding study start
- Subjects who have given their written informed consent.
Exclusion
- Inhibitors or history of inhibitors
- History of adverse reactions related to Factor VIII
- Platelet count \<90,000 /µl
- Subjects on prophylaxis treatment
- Subjects with concomitant debilitating disease (e.g. cancer, non-controlled diabetes, heart insufficiency, renal failure)
- Subjects with known sensitivity to blood products
- Subjects who have participated in another Ethical Committee approved Clinical Trial (including medical device studies) within the past 30 days
- Subjects with a weight over 86 kg or below 50 kg
- Subjects who do not understand or are not willing to comply with the requirement of the study protocol
- Subjects who cannot differentiate a bleeding episode from other causes of joint pain
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00245297
Start Date
October 1 2005
End Date
April 1 2006
Last Update
October 16 2007
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Hematological Research, Department of Reconstructive Orthopedic Surgery
Moscow, Russia, 125167
2
The Russian Academy of Medical Sciences, Haemophilia Center
Moscow, Russia, 125167
3
Republic Haemophilia Center.
Saint Petersburg, Russia, 191186