Linperlisib in the Treatment of aPRCA

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Acquired Pure Red Cell Aplasia
Interventions
DRUG

Linperlisib

Linperlisib 40 mg, orally, once daily. Following 2 weeks of treatment, efficacy was assessed. If the reticulocyte count remained \<20×10⁹/L, the dose was escalated to 60 mg, once daily. After an additional 2 weeks of therapy, a second efficacy assessment was performed. Patients failing to achieve partial response (PR) underwent further dose escalation to 80 mg, once daily. Treatment was discontinued if PR was not attained after 8 weeks at the maximum dose. Responding patients maintained therapy at their effective dose level. The core study period comprised 12 weeks, with responders continuing treatment at the investigator's discretion.

Trial Locations (1)

100730

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER