Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia (NCT04737850) | Clinical Trial Compass
CompletedPhase 3
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
China100 participantsStarted 2021-03-29
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
the main parameters in population PK/PD modeling in Part A
Timeframe: from baseline to Week 2
2
the proportion of patients with a platelet count ≥50×10^9/L at week 10.