CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Emicizumab Injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04188639
NCT04188639Phase 2Completed
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Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial

GWT-TUD GmbH·interventional·Posted Dec 6, 2019·Updated Jan 9, 2023

In Brief

A Phase 2 clinical trial evaluating Emicizumab Injection for Hemophilia A, Acquired. Completed, enrolled 47 participants across 16 sites in 2 countries.

Detailed Summary

This study is an international, multicenter, open-label, single arm, prospective clinical trial and will evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A, Acquired
CountriesAustria, Germany
CollaboratorsHoffmann-La Roche, Hannover Medical School

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 6, 2019
Enrollment StartMar 23, 2021
Primary CompletionJan 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.6 years ago

Interventions

Emicizumab Injectiondrug

All eligible patients with AHA will receive the same study medication consisting of once weekly subcutaneous emicizumab. For each subject, the maximal duration of the study will be 24 weeks including 12 weeks treatment with emicizumab and 12 weeks follow-up with Immunosuppressive therapy (IST) at the investigators discretion.