Status:
COMPLETED
PF-06741086 Long-term Treatment in Severe Hemophilia
Lead Sponsor:
Pfizer
Conditions:
Hemophilia A or B
Eligibility:
MALE
12-74 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety, tolerability and efficacy of long-term treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month Phase 1b/2 B7841002 ...
Eligibility Criteria
Inclusion
- Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%)
- Subjects enrolled as Factor VIII or Factor IX inhibitor patients must have a positive inhibitor test result (above the upper limit of normal) at the local laboratory and must receive a bypass agent as primary treatment for bleeding episodes.
- Episodic (on-demand) treatment regimen prior to screening
- At least 6 acute bleeding episodes during the 6-month period prior to screening
Exclusion
- Known coronary artery, thrombotic, or ischemic disease
- Concomitant treatment with activated prothrombin complex concentrate
Key Trial Info
Start Date :
May 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03363321
Start Date
May 30 2018
End Date
August 5 2020
Last Update
July 27 2021
Active Locations (8)
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1
UC Denver Hemophilia and Thrombosis Center
Aurora, Colorado, United States, 80045
2
Centro de Hematologia e Hemoterapia de Campinas- Hemocentro de Campinas
Campinas, São Paulo, Brazil, 13083-878
3
Hospital Dr. Sotero del Rio
Santiago, Puente ALTO, Chile, 8207257
4
Klinicki bolnicki centar Zagreb
Zagreb, Croatia, 10000