Clinical Trial: A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura
Brief Summary: The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP.
Detailed Summary:
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Current Primary Outcome: The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: up to Day 28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Plasma pharmacokinetic (PK) parameters of Hetrombopag after multiple dose from day 1 to day 14, composite including AUC, Cmax, Tmax, and t1/2 [ Time Frame: day 1 and day 14 ]
- The proportion of patients with platelet counts ≥50,000/µL after treatment [ Time Frame: up to Day 28 ]
Original Secondary Outcome: Same as current
Information By: Jiangsu HengRui Medicine Co., Ltd.
Dates:
Date Received: March 20, 2015
Date Started: April 2014
Date Completion:
Last Updated: March 30, 2015
Last Verified: March 2015
