CTIS2023-505747-40-00
Recruiting
Phase 1
A Multicenter, Open-Label Phase IV Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes, in Participants Aged =13 and < 70 Years with Severe or Moderate Hemophilia a Without FVIII Inhibitors on Emicizumab Prophylaxis - MO42623
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Severe or Moderate Hemophilia A
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 136
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of severe congenital hemophilia A (intrinsic FVIII level \<1%) or moderate congenital hemophilia A (intrinsic FVIII level \= 5%) if previously prescribed prophylaxis, A negative test for FVIII inhibitor (i.e., \<0\.6 BU) during screening period, No history of FVIII inhibitory antibodies (\<0\.6 BU/mL using the Bethesda assay) in the last 5 years. Participants who completed successful immune tolerance induction (ITI) at least 5 years before screening are eligible, provided they have had no evidence of inhibitor recurrence (permanent or temporary) as may be indicated by detection of an inhibitor, FVIII half\-life \<6 hours, or FVIII recovery \< 66% since completing ITI, Participants who were on standard FVIII prophylaxis, defined as the regular administration of FVIII to prevent bleeding, for at least the last 24 weeks, can be enrolled regardless of the number of bleeds during this period, Adequate hematologic, hepatic and renal function, For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 24 weeks after the final dose of emicizumab
Exclusion Criteria
- •Inherited or acquired bleeding disorder other than severe congenital hemophilia A (intrinsic FVIII level \<1%) or moderate congenital hemophilia A (intrinsic FVIII level \= 5%) without FVIII inhibitors who were previously prescribed prophylaxis for at least 24 weeks, Participants who have previously received emicizumab prophylaxis, Participants that plan to have joint replacement, joint procedure, synovectomy or synoviorthesis at screening, Participants who had joint replacement, joint procedure, synovectomy or synoviorthesis: – Less than 2 years ago OR – More than 3 years ago and are still experiencing pain in the joint For participants who had joint replacement, joint procedure, synovectomy or synoviorthesis more than 2 years ago who are not experiencing pain in the joint, the participant may be enrolled but the specific joint in which the procedure was conducted will be excluded from the study, Participants who have conditions other than hemophilia A that can affect joint health and structure (e.g., osteoarthritis) or with severely impaired mobility due to conditions other than hemophilia A
Outcomes
Primary Outcomes
Not specified
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