JPRN-jRCTs041200037
Active, not recruiting
Phase 4
A prospective, multicenter study to evaluate the safety of emicizumab under and after immune tolerance induction in patients with congenital hemophilia A with FVIII inhibitors
Matsushita Tadashi0 sites15 target enrollmentAugust 3, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Congenital hemophilia A with FVIII inhibitors
- Sponsor
- Matsushita Tadashi
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet all of the following criteria for study entry:
- •1\) Informed Consent Form signed by the patient or the patient's legally authorized representative. Pediatric patients who are capable: Informed Assent Form signed by the patient
- •2\) Patient or caregiver: Willing and able to comply with all study procedures (including filling out questionnaires on bleeds/drugs used)
- •3\) Diagnosed with congenital hemophilia A and meets either of the following criteria:
- •a. Will start ITI after study enrollment and has positive FVIII inhibitor titer ( \>\= 0\.6 BU/mL) as evidenced by most recent titer results within 8 weeks before enrollment
- •b. Is already undergoing ITI at study enrollment and has not yet met partial success as evidenced by most recent titer results within 8 weeks before enrollment
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from study entry:
- •1\) Inherited or acquired bleeding disorder other than congenital hemophilia A
- •2\) Previous (within the last 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter\-associated thrombosis for which anti\-thrombotic treatment is not currently ongoing) or high risk for thromboembolic diseases(e.g. protein S deficiency)
- •3\) At high risk for thrombotic microangiopathy (TMA) in the opinion of the investigator based on previous or familial history of TMA (e.g., thrombotic thrombocytopenic purpura \[TTP], atypical hemolytic uremic syndrome \[aHUS])
- •4\) Participating or planning to participate in other intervention trials
- •5\) Otherwise unsuitable for study participation in the opinion of the investigator
Outcomes
Primary Outcomes
Not specified
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