ISRCTN58752772
Active, Not Recruiting
N/A
on-interventional study to investigate the effectiveness of emicizumab under real-world conditions in pediatric, adolescent, adult and elderly patients with hemophilia A with and without FVIII inhibitors
Roche (Germany)0 sites168 target enrollmentFebruary 9, 2022
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Roche (Germany)
- Enrollment
- 168
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants of any age with congenital severe haemophilia A with or without FVIII inhibitors
- •2\. Participants undergoing treatment with emicizumab according to Summary of Product Characteristics (SPC) (start of treatment with emicizumab maximum 3 months prior to study entry)
- •3\. Must sign informed consent by the legal representative or participant or both, as required
- •4\. Selection criteria for Cohort A include participants diagnosed with severe congenital haemophilia A (\<1% FVIII activity) and no present FVIII inhibitor at the start of emicizumab treatment, patients who completed successful ITI before the start of Emicizumab treatment are eligible.
- •5\. Selection criteria for Cohort B include participants diagnosed with congenital haemophilia A (any severity) with FVIII inhibitor activity at the start of emicizumab treatment or ongoing ITI at the start of emicizumab treatment
Exclusion Criteria
- •1\. Participants having bleeding disorder other than congenital haemophilia A
- •2\. Treatment with emicizumab outside of the SPC at study entry
- •3\. Any contraindication for treatment with emicizumab according to current SPC
- •4\. Current participation in an interventional study
Outcomes
Primary Outcomes
Not specified
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