A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in Eltrombopag-inefficient or Relapsed ITP
- Registration Number
- NCT03754634
- Lead Sponsor
- Shandong University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description drugs Eltrombopag and Diacerein Eltrombopag and Diacerein
- Primary Outcome Measures
Name Time Method Evaluation of platelet response the sixth weeks R. A response (R) was defined as platelet count ≥ 30×10\^9/L without bleeding
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Qilu hospital, Shandong University
🇨🇳Jinan, Shandong, China