NCT03222843

Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

A Phase III,Multicentre, Randomized, Double-Blind and Open-Label Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Idiopathic Thrombocytopenic Purpura

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with chronic, previously treated ITP. Dosage could be adjusted (2.5\~.75 mg/day) to maintain platelet counts 50\~250×109/L

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	Hetrombopag Olamine	once daily
DRUG	matching placebo	once daily

Timeline

• Start date: 2017-06-30
• Primary completion: 2019-11-11
• Completion: 2021-01-07
• First posted: 2017-07-19
• Last updated: 2022-08-03

Locations

3 sites across 1 country: China