Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Qilu Hospital of Shandong University
Updated on 5 December 2022
platelet count
eltrombopag

Summary

Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder with low platelet count. As the first choice of the second-line treatment of ITP, thrombopoietin receptor agonist (TPO-RA) enable long-term remission in 50% to 60% of cases. However, about half of patients have no response or loss of response due to unknown reasons, which can't be effectively improved by increasing the drug dose. Diacerein is a slow-acting medicine of the class anthraquinone used to treat joint diseases such as osteoarthritis. We speculate that the addition of diacerein to eltrombopag may offer sensitizer effect and maximize efficacy, and serve as an optimized second-line treatment for ITP patients.

Description

In this multicentre, open-label, randomized controlled trial, 100 eltrombopag-inefficient or relapsed ITP patients will be enrolled from five tertiary medical centres in China. Participants will be randomly assigned into the combination group (eltrombopag orally at initial dose of 75 mg daily for 14 days, plus diacerein orally at initial dose of 50 mg bid for 14 days) or the monotherapy group (eltrombopag orally at initial dose of 75 mg daily for 14 days) by masked statisticians in a 1:1 ratio. The primary endpoints are initial response at D15 without any additional ITP-specific intervention. The secondary outcomes include response at D28, time to response, duration of response, bleeding score, health-related quality of life assessment, and safety issue. Full analysis set, including all participants who receive allocated intervention and have a valid baseline data, and at least 1 valid post-baseline platelet count measurement, will be used to assess efficacy.This study will compare the efficacy and safety of eltrombopag-diacerein with eltrombopag monotherapy in adults with primary immune thrombocytopenia. The results of this study will provide evidence for the sensitizer effect of diacerein to eltrombopag, and offer an optimized second-line treatment for ITP patients.

Details
Condition Thrombocytopenia and Thrombocytopenia Prevention, Thrombocytopenia
Treatment Eltrombopag, Eltrombopag plus diacerein
Clinical Study IdentifierNCT04917679
SponsorQilu Hospital of Shandong University
Last Modified on5 December 2022

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note