CompletedPhase 3
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
Key facts
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 100 people enrolled
- Started
- 29 Mar 2021
- Ended
- 17 Jun 2025
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Hetrombopag
- Placebo
- Record updated
- 18 July 2025
Who can take part
- Age
- 6 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Age ≥ 6 years old and ≤ 17 years old,both sexes
- Part A:Confirmed diagnosis of ITP ≥6months; Part B: Confirmed diagnosis of ITP ≥12months;Platelets <30×10\^9/L twice in a row,and platelets <30×10\^9/L before taking the medicine
- Subjects who are refractory or have relapsed after at least one prior ITP therapy
- Birth control during and 28 days after the trial
- Written informed consent must be obtained from the patient's guardian and accompanying informed assent from the patient (for children over 8 years old)
Who cannot take part
- Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia
- Participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to medication
- Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness
- Active HIV or HCV-Ab positive,HBsAg positive
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
- ALT, AST, or ALP> 1.5 x upper limit of normal (ULN), DBLI, or Scr > 1.2 x upper limit of normal (ULN)
- PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s
- No evidence of other causes of thrombocytopenia
- Diagnosis as Evans or Wiskott-Aldrich comprehensive
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- PartA, open-labelTreatment being tested
Hetrombopag plus standard of care
Treatment: Hetrombopag
- PartB, double-blind treatment groupTreatment being tested
Hetrombopag plus standard of care
Treatment: Hetrombopag
- Placebo ComparatorPlacebo, for comparison
Placebo plus standard of care Part B, double-blind treatment group
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety and Efficacy of Hetrombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia:a Randomized, Multicenter, Placebo-controlled Trial
- Publications
- Record updated
- 18 July 2025