Status:
TERMINATED
Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A
Lead Sponsor:
Bio Products Laboratory
Conditions:
Haemophilia A
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma inhibitor levels for at least 100 Exposure Days (EDs) for each subject. Secondary objectives: To assess ef...
Detailed Description
The primary efficacy endpoint is to assess immunogenicity of Optivate® by monitoring plasma inhibitor level for at least 100 EDs for each subject. FVIII inhibitor evaluation FVIII inhibitor screen da...
Eligibility Criteria
Inclusion
- Written informed consent or, if less than 18 years of age written assent (where possible) and their parent/guardian's written informed consent.
- Severe haemophilia A (\< 1%# FVIII:C).
- Previously Treated Patients (PTPs) with \> 150 exposure days on prior Factor VIII therapy (of which at least the last 50 EDs or 2 years treatment can be confirmed by way of subject records).
- Immunocompetent with CD4 count \> 200 / µl.
- HIV negative or a viral load \< 200 particles / µl.
- subjects suffering from severe haemophilia A (\<2%) may be enrolled, but only after approval by BPL. Subjects with a Factor VIII of \<2% may not constitute more than 50% of the total patient population. A separate statistical evaluation will be conducted for the \<1% and \<2% populations.
Exclusion
- • History of inhibitor development to FVIII or a positive result on the Nijmegen Bethesda at screening (quantitative result of \> 0.6 BU) prior to the administration of Optivate®.
- Known or suspected hypersensitivity to the investigational medicinal product or its excipients.
- Clinically significant liver disease, renal disease, or coagulopathy other than haemophilia A.
- History of unreliability or non cooperation (including not being able to complete the study diary).
- Participating in, or have taken part in another trial within the last 30 days.
Key Trial Info
Start Date :
November 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01811875
Start Date
November 21 2014
End Date
August 31 2017
Last Update
July 22 2021
Active Locations (4)
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1
Fundacion BIOS
Barranquilla, Colombia, 80-216
2
Hospital general de Medellin
Medellín, Colombia, 32-102
3
HZRM Haemophilia Centre Rhine Main
Darmstadt, Mörfelden-Walldorf, Germany, 64546
4
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, Poland, 93-513