Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient
Study Details
Study Description
Brief Summary
A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with chronic, previously treated ITP. Dosage could be adjusted (2.5~.75 mg/day) to maintain platelet counts 50~250×109/L
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 oral hetrombopag at an initial dose of 2.5 mg once daily |
Drug: Hetrombopag Olamine
once daily
|
| Experimental: Arm 2 oral hetrombopag at an initial dose of 5 mg once daily |
Drug: Hetrombopag Olamine
once daily
|
| Placebo Comparator: Arm 3 oral placebo at an initial dose of 2.5 mg once daily |
Drug: matching placebo
once daily
|
| Placebo Comparator: Arm 4 oral placebo at an initial dose of 5 mg once daily |
Drug: matching placebo
once daily
|
Outcome Measures
Primary Outcome Measures
- the proportion of patients with a platelet count ≥50×109/L after Day 57. [Baseline to Week 8]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed diagnosis of ITP ≥6 months;Platelets <30×109/L.
-
No evidence of other causes of thrombocytopenia.
-
Subjects who are refractory or have relapsed after at least one prior ITP therapy.
-
Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
-
Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
-
PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
-
Signed informed consent.
Exclusion Criteria:
-
Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
-
Subjects diagnosed with tumor.
-
Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.
-
Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
-
Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days .
-
Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study.
-
Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.
-
ALT> 1.5 x upper limit of normal (ULN), AST> 3 x upper limit of normal (ULN)) DBLI> 1.2 x upper limit of normal (ULN),Scr> 1.2 x upper limit of normal (ULN)
-
The subject has participated in other clinical trial within the 3 months prior to randomization.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Union Hospital Tongji Medical College Huazhong University of Science and technology | Wuhan | Hubei | China | 430022 |
| 2 | West China Hospital，Sichuan University | Chengdu | Sichuan | China | 610041 |
| 3 | Hospital of Blood Diseases, Chinese Academy of Medical Sciences | Tianjin | Tianjin | China | 300041 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HR-TPO-III-ITP