NCT01811875

Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A

Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 efficacy and tolerability by monitoring FVIII recovery and adverse events

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 data will be listed. FVIII quantitative inhibitor results will be listed. Shift tables will present the number of subjects with positive (≥ 0.6 BU) and negative (\< 0.6 BU) results and those for whom the results change during the study. The number of exposure days until development of inhibitors will be summarised. For the secondary endpoints: Descriptive statistics will be presented on the number of recoveries at each timepoint and for each subject. These will be presented for each visit and for each subject and then for each batch of FVIII/ Optivate® used. All the AE data (from CRF and study diary) will be pooled together and reported in terms of the type, duration, treatment and/or severity.

Conditions

• Haemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Optivate 500IU

Timeline

• Start date: 2014-11-21
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2013-03-15
• Last updated: 2021-07-22
• Results posted: 2021-07-22

Locations

4 sites across 3 countries: Colombia, Germany, Poland