Status:
COMPLETED
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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 p...
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 chroni...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- No evidence of other causes of thrombocytopenia.
- Diagnosis as Evans or Wiskott-Aldrich comprehensive.
- Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia.
- Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness.
- ALT, AST, or ALP\> 1.5 x upper limit of normal (ULN), DBLI, or Scr \> 1.2 x upper limit of normal (ULN).
- Active HIV or HCV-Ab positive,HBsAg positive.
- PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s
- Participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to medication.
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04737850
Start Date
March 29 2021
End Date
June 17 2025
Last Update
July 18 2025
Active Locations (1)
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1
Beijing children's hospital .Capital medical university
Beijing, Beijing Municipality, China, 100032