PF-06741086 Long-term Treatment in Severe Hemophilia

Completed · Phase 2

Conditions studied: Hemophilia A or B

In brief

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.

Key facts

Study ID

NCT03363321

Run by

Pfizer

People needed

20

Starts

2018-05-30

Expected to finish

2020-08-05

Last updated by the study team

2021-07-27

Who can join

Age: 12 and older, up to 74. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known coronary artery, thrombotic, or ischemic disease
• Concomitant treatment with activated prothrombin complex concentrate

Where it is running

• UC Denver Hemophilia and Thrombosis Center — Aurora, Colorado, United States
• Centro de Hematologia e Hemoterapia de Campinas- Hemocentro de Campinas — Campinas, São Paulo, Brazil
• Hospital Dr. Sotero del Rio — Santiago, Puente ALTO, Chile
• Klinicki bolnicki centar Zagreb — Zagreb, Croatia
• Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• Phoenix Pharma (Pty) Ltd — Port Elizabeth, Eastern Cape, South Africa
• Charlotte Maxeke Johannesburg Academic Hospital — Johannesburg, Gauteng, South Africa
• UniversitatsSpital Zurich — Zurich, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.