NCT04737850

Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

Safety and Efficacy of Hetrombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia：a Randomized, Multicenter, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy, safety of Hetrombopag in children with previously treated chronic immune thrombocytopenia who are between 6 and 17 years of age. This is a 2 part study. In part A, patients will receive Hetrombopag for 8 weeks. In part B, all patients will receive Hetrombopag for 24 weeks.

Detailed description

This is a two-part, double-blind, randomized, placebo-controlled, and open-label Phase III study to investigate the efficacy, safety of Hetrombopag in pediatric patients with previously treated chronic ITP. In Part A, patients will receive Hetrombopag for 8 weeks. After completing Part A, patients will begin Part B, in which they will be randomized to receive Hetrombopag or placebo in a 12 week double-blind, placebo-controlled treatment period, following an open-label 12 week treatment period.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Hetrombopag	Thrombopoietin receptor agonist
DRUG	Placebo	Placebo with no active pharmaceutical ingredient

Timeline

• Start date: 2021-03-29
• Primary completion: 2024-12-31
• Completion: 2025-06-17
• First posted: 2021-02-04
• Last updated: 2025-07-18

Locations

1 site across 1 country: China