drugset / Trial / NCT03557099

A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia (SAA) Patient

NCT03557099

Phase 1/2 Completed 55 enrolled Jiangsu HengRui Medicine Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a Multicentre, Open-label, single-arm, Phase II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic Anemia. 55 adult patients with SAA will be enrolled in the study. Treatment with Hetrombopag will be started at 7.5 mg/day and uptitrated according to the platelet count. The primary objective of the study is to assess the safety and efficacy of Hetrombopag in patients with SAA.

Timeline

Start
2018-06-20
Primary completion
2019-10-31
Completion
2020-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Hetrombopag Small molecule 15 mg Oral

Indications