ABOUT THIS STUDY
- Participants with a diagnosis of severe hemophilia A or B with a minimum weight of 30 kg at screening.
- Participant or legally authorized representative, or participant's caregiver capable of giving signed informed consent (or minor assent, when applicable).
Participants who are enrolled into the Non-Inhibitor Cohort must also meet the following criteria:
- No detectable or documented history of inhibitors
- Participants on FVIII/FIX routine prophylaxis who have demonstrated at least 80% compliance with scheduled prophylaxis regimen during 6 months prior to enrollment and are willing to continue to receive routine prophylaxis treatment with FVIII/FIX replacement during the Observational Phase.
- Participants with on-demand treatment regimen with ≥6 acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months period prior to enrollment and willing to continue to receive on demand treatment during the Observational Phase.
Participants who are enrolled into the Inhibitor Cohort must also meet the following criteria:
- Documentation of current high titer inhibitor (≥5 BU/mL) or current low titer inhibitor (<5 BU/mL) refractory to FVIII or FIX replacement and with FVIII or FIX recovery <60% of expected within previous 6 months prior to enrolment into the Observational Phase
- Participants with on-demand treatment regimen with ≥6 bleeding episodes (spontaneous and/or traumatic) necessitating treatment with bypass factor during the 6 months prior to enrollment in the Observation Phase and willing to continue to receive on-demand treatment during this phase.
- Participants who have documented inhibitors while on factor-replacement therapy but who do not meet the quantitative inhibitor criteria described in the prior bullet at the time of Screening (eg, participant with a previously documented high-titer inhibitor (≥5 BU/mL) and whose condition precludes re-challenge with FVIII or FIX replacement) may be considered for eligibility on a case-by-case basis with prior approval from the Pfizer Medical Monitor
- 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-
- Regular, concomitant therapy with immunomodulatory drugs
- Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX
replacement during the Active Treatment Phase.
- Previous exposure to PF 06741086 during to participation in studies B7841002 and
- Participation in other studies involving investigational drug(s) within 30 days (or as
determined by local requirements) or 5 half-lives prior to study entry and/or during
- 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.
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