Last reviewed · How we verify
The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
The sample size of this study is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients achieved a response, then enrollment was expanded to a total of 26 patients. The null hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 33 patients.
Details
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
|---|---|
| Phase | PHASE2 |
| Status | UNKNOWN |
| Enrolment | 33 |
| Start date | Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Dec 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Refractory/Relapsed Autoimmune Hemolytic Anemia
Interventions
- Zanubrutinib
Countries
China