Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

December 1, 2021

Study Completion Date

June 1, 2022

Conditions
Thrombocytopenia
Interventions
DRUG

Eltrombopag plus diacerein

In the combination group, eltrombopag will be administered orally at an initial dose of 75mg daily for 14 days, and diacerein will be given orally at an initial dose of 50mg bid concomitantly for 14 days (D1-D14). During treatment period, treating physicians will modify the dosage of trial treatment to maintain participants' platelet count at the range of 50 - 150 × 10\^9/L as follows: (1) if platelet count is less than 150 × 10\^9/L, continue the original treatment (eltrombopag 75mg daily plus diacerein 50mg bid); (2) if platelet count is between 150 × 10\^9/L to 250 × 10\^9/L, the treatment will be modified to eltrombopag 50mg daily plus diacerein 50mg bid; (3) if platelet count is over 250 × 10\^9/L, original treatment (both eltrombopag and diacerein) need to be stopped, and platelet count should be reexamined every other day, and the treatment (eltrombopag 50mg daily plus diacerein 50mg bid ) will be restarted until platelet count is below 100 × 10\^9/L.

DRUG

Eltrombopag

In the monotherapy group, eltrombopag also will be administered orally at an initial dose of 75mg daily for 14 days (D1-D14), and the individualized dosage could be modified by treating physicians to maintain participants' platelet count between 50 × 10\^9/L to 150 × 10\^9/L.

Trial Locations (1)

Unknown

Qilu hospital, Shandong University, Jinan

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER

NCT04917679 - Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP | Biotech Hunter | Biotech Hunter