A Clinical Trial of Chidamide in the Management of Refractory ITP

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

September 1, 2022

Study Completion Date

September 1, 2023

Conditions
Thrombocytopenia
Interventions
DRUG

Chidamide

In the 2.5 mg group, chidamide will be administered orally at an initial dose of 2.5 mg twice per week for 12 weeks. If an initial response was achieved by week 12, the allocated treatment could continue. Patients in 2.5 mg group were allowed to increase dose to 5 mg if platelet counts were less than 30×10\^9 cells per L or less than two-times increase from baseline platelet count at week 12 according to investigators' advice and the patients' decision.

DRUG

Chidamide

In the 5 mg group, chidamide will be administered orally at an initial dose of 5 mg twice per week for 12 weeks. If an initial response was achieved by week 12, the allocated treatment could continue. Patients who did not respond to chidamide at 5 mg for 12 weeks would stop the allocated treatment and were continuously followed up.

Trial Locations (1)

Unknown

Qilu hospital, Shandong University, Jinan

All Listed Sponsors
lead

Shandong University

OTHER