A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in Eltrombopag-inefficient or Relapsed ITP

September 10, 2023 updated by: Ming Hou, Shandong University

A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in the Management of Eltrombopag-inefficient or Relapsed ITP

Eltrombopag is an oral thrombopoietin receptor agonist that has been licensed for use as second line therapy in ITP patients. Diacerein is a slow-acting medicine of the class anthraquinone used to treat joint diseases such as osteoarthritis. The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in China. In order to report the efficacy and safety of eltrombopag combined with diacerein in the management of ITP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are undertaking a prospective, open, multicentre trial of 30 ITP adult patients with eltrombopag-inefficient or relapsed from 6 medical centers in China. The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.

Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of eltrombopag combined with diacerein for the treatment of adults patients with eltrombopag-inefficient or relapsed.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ITP patients with eltrombopag-inefficient or relapsed need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

  • pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drugs
Eltrombopag and Diacerein
Drug: Eltrombopag and Diacerein
The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.
Other Names:
  • diacetylrhein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of platelet response
Time Frame: the sixth weeks
R. A response (R) was defined as platelet count ≥ 30×10^9/L without bleeding
the sixth weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Shenzhen Second People's Hospital
The First Affiliated Hospital of Dalian Medical University
Anhui Medical University
Zhejiang Provincial Hospital of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

November 25, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP-Diacerein

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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