PF-06741086 Long-term Treatment in Severe Hemophilia
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - 74 |
| Updated: | 3/1/2019 |
| Start Date: | May 30, 2018 |
| End Date: | May 22, 2020 |
| Contact: | Pfizer CT.gov Call Center |
| Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
| Phone: | 1-800-718-1021 |
A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA
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 study. Additionally, de novo subjects will be recruited into this study.
treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month
Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.
Inclusion Criteria:
- 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 Criteria:
- Known coronary artery, thrombotic, or ischemic disease
- Concomitant treatment with activated prothrombin complex concentrate
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