drugset / Trial / NCT04188639
Emicizumab in Acquired Hemophilia A
Phase 2
Completed
47 enrolled
GWT-TUD GmbH
Hannover Medical School · collabHoffmann-La Roche · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-03-23
- Primary completion
- 2023-01-04
- Completion
- 2023-01-04
Publications
- Turkantoz H, Dobbelstein C, Greil R, Hart C, Klamroth R, Knobl P, Oldenburg J, Pfrepper C, Sachs U, Schimansky IM, Trautmann-Grill K, Tiede A. Management of Breakthrough Bleeding During Emicizumab Prophylaxis in Acquired Haemophilia A: Data From the GTH-AHA-EMI Study. Haemophilia. 2026 Jun 15. doi: 10.1111/hae.70339. Online ahead of print.
- Schimansky IM, Dobbelstein C, Klamroth R, Hart C, Sachs UJ, Greil R, Knobl P, Oldenburg J, Miesbach W, Pfrepper C, Trautmann-Grill K, Mohnle P, Holstein K, Eichler H, Werwitzke S, Tiede A. Sustained survival benefit of emicizumab and postponed immunosuppression in acquired hemophilia A. Blood Adv. 2025 Nov 25;9(22):5853-5860. doi: 10.1182/bloodadvances.2025017144.
- Tiede A, Hart C, Knobl P, Greil R, Oldenburg J, Sachs UJ, Miesbach W, Pfrepper C, Trautmann-Grill K, Holstein K, Pilch J, Mohnle P, Schindler C, Weigt C, Schipp D, May M, Dobbelstein C, Pelzer FJ, Werwitzke S, Klamroth R. Emicizumab prophylaxis in patients with acquired haemophilia A (GTH-AHA-EMI): an open-label, single-arm, multicentre, phase 2 study. Lancet Haematol. 2023 Nov;10(11):e913-e921. doi: 10.1016/S2352-3026(23)00280-6. Epub 2023 Oct 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Emicizumab | Monoclonal antibody | 1.5 mg/kg | Subcutaneous |