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About
Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly (QW) subcutaneous (SC) administration provides for treatment options in the absence of reliable vascular access, increased convenience and may enable better compliance. Combined, these qualities should result in a reduction of bleeding episodes.
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Inclusion and exclusion criteria
Inclusion Criteria
Participants who are enrolled into the Non-Inhibitor Cohort must also meet the following criteria:
Participants who are enrolled into the Inhibitor Cohort must also meet the following criteria:
Exclusion Criteria
Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis or ischemic disease
Known planned surgical procedure during the planned study period.
Known hemostatic defect other than hemophilia A or B.
Abnormal renal or hepatic function
Current unstable liver or biliary disease
Abnormal hematologic parameters
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator,
Current routine prophylaxis with bypassing agent or non-coagulation non-factor- replacement therapy, or any previous treatment with a gene therapy product for treatment of hemophilia (participants treated with prophylaxis using bypassing agents or who had prior treatment with non-factor products may be considered on a case-by-case basis).
Regular, concomitant therapy with immunomodulatory drugs
Previous exposure to PF 06741086 during participation in studies B7841002 and B7841003.
Participation in other studies involving investigational drug(s) or investigational vaccines within 30 days (or as determined by local requirements) or 5 half-lives prior to study entry and/or during study participation.
CD4 cell count ≤200/uL if human immunodeficiency virus (HIV)-positive
Screening ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Individuals with hypersensitivity or an allergic reaction to hamster protein or other components of the study intervention.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Primary purpose
Allocation
Interventional model
Masking
186 participants in 1 patient group
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Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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