Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Confirmed diagnosis of ITP ≥12 months; Platelets <30×109/L.

2. Subjects who are refractory or have relapsed after at least one prior ITP therapy.

3. Previous therapy for ITP including rescue must have been completed at least 21 days prior to randomization.

4. Subjects treated with maintenance therapy(such as Corticosteroids, Azathioprine, and Azathioprine) must be receiving a dose that has been stable for at least 14 days,30days, and 60 days respectively.

5. 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:

1. No evidence of other causes of thrombocytopenia.

2. Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia.

3. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days.

4. ALT, AST, or ALP> 1.5 x upper limit of normal (ULN), DBLI, or Scr > 1.2 x upper limit of normal (ULN).

5. PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s

6. Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness.