NCT06021977

The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

A Phase II, Single Center, Open-label Trial to Determine the Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 6 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Refractory/Relapsed Autoimmune Hemolytic Anemia

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Zanubrutinib was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2023-09-01
• Last updated: 2023-11-29

Locations

1 site across 1 country: China