Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
NCT04737850 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-07-18
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.
Conditions
Interventions
- DRUG
-
Hetrombopag
Thrombopoietin receptor agonist
- DRUG
-
Placebo with no active pharmaceutical ingredient
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-29
- Primary Completion
- 2024-12-31
- Completion
- 2025-06-17
Countries
- China
Study Locations
More Related Trials
-
Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
NCT06168851 ·Status: RECRUITING ·Phase: PHASE2
-
Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)
NCT06838962 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
NCT02614846 ·Status: UNKNOWN ·Phase: PHASE1
-
Eltrombopag Phase III Study In Chinese Chronic ITP Patients
NCT01762761 ·Status: COMPLETED ·Phase: PHASE3
-
A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)
NCT06094881 ·Status: RECRUITING ·Phase: PHASE2
-
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
NCT06291415 ·Status: WITHDRAWN ·Phase: PHASE1
-
Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children
NCT03939637 ·Status: COMPLETED ·Phase: PHASE3
-
to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection
NCT03664518 ·Status: COMPLETED ·Phase: PHASE2
-
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.
NCT03976882 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
NCT02279173 ·Status: COMPLETED ·Phase: PHASE3
-
Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient
NCT03222843 ·Status: COMPLETED ·Phase: PHASE3
-
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
NCT05864014 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP)
NCT00908037 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
NCT01444417 ·Status: COMPLETED ·Phase: PHASE3
-
The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia
NCT03201848 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Eltrombopag in Chronic ITP
NCT04102033 ·Status: UNKNOWN ·Phase: PHASE4
-
A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
NCT02201290 ·Status: COMPLETED ·Phase: PHASE3
-
Longitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP)
NCT06107582 ·Status: RECRUITING
-
TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)
NCT05718856 ·Status: RECRUITING ·Phase: PHASE4
-
Observational Study: Hetrombopag for Platelet Recovery in Haploidentical HSCT
NCT07003269 ·Status: ENROLLING_BY_INVITATION
-
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
NCT00102739 ·Status: COMPLETED ·Phase: PHASE2
-
TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
NCT06478537 ·Status: RECRUITING ·Phase: PHASE2
-
Safety of Oral Thrombopoietin Receptor Agonist in Pediatric Chronic ITP
NCT05846529 ·Status: UNKNOWN
-
An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA
NCT05333861 ·Status: NOT_YET_RECRUITING
-
A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults
NCT07083739 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2