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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