NCT03754634

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-06-01
• Completion: 2020-11-01
• First posted: 2018-11-27
• Last updated: 2023-09-13

Locations

1 site across 1 country: China