ABOUT THIS STUDY
- Participants with a diagnosis of severe hemophilia A or B
- 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 outside the US and Canada with FVIII/FIX replacement, and willing to continue to receive routine prophylaxis treatment with FVIII/FIX replacement during the Observational Phase. Participants in the US and Canada receiving routine prophylaxis treatment not eligible to be enrolled.
- Participants with on-demand treatment regimen with ≥6 acute bleeding episodes (spontaneous and/or traumatic) that required coagulation factor infusion during the 6 months period prior to Screening and willing to continue to receive on demand treatment during the Observational 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.
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 30 days prior to Baseline of Observational Phase
- Participants with on-demand treatment regimen with ≥6 bleeding episodes (spontaneous and/or traumatic) necessitating treatment with bypass factor for at least 6 months prior to screening and willing to continue to receive on-demand treatment during the Observational Phase.
- 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
- Abnormal coagulation activity
- 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
- Clinically relevant ECG 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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