Clinical trial NCT03222843: Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient
Official title: A Phase III,Multicentre, Randomized, Double-Blind and Open-Label Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Idiopathic Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: ITP
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-19
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of ITP ≥6 months;Platelets \<30×109/L.
2. No evidence of other causes of thrombocytopenia.
3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.
4. Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
5. Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
6. PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
7. Signed informed consent.

Exclusion Criteria:

1. Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
2. Subjects diagnosed with tumor.
3. 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.
4. Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
5. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days .
6. 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.
7. 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.
8. 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)
9. The subject has participated in other clinical trial within the 3 months prior to randomization.

Primary outcomes:
measure: the proportion of patients with a platelet count ≥50×109/L after Day 57.
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and technology
state: Hubei
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Hospital of Blood Diseases, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References:
citation: Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, Hou M, Yao Y, Liu L, Wang Y, Wu D, Zhang L, Zheng C, Shen X, Hu Q, Liu J, Jin J, Luo J, Zeng Y, Gao S, Zhang X, Zhou X, Shi Q, Xia R, Xie X, Jiang Z, Gao L, Bai Y, Li Y, Xiong J, Li R, Zou J, Niu T, Yang R, Hu Y. Dose tapering to withdrawal stage and long-term efficacy and safety of hetrombopag for the treatment of immune thrombocytopenia: Results from an open-label extension study. J Thromb Haemost. 2022 Mar;20(3):716-728. doi: 10.1111/jth.15602. Epub 2021 Dec 15.
citation: Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, Hou M, Yao Y, Liu L, Wang Y, Wu D, Zhang L, Zheng C, Shen X, Hu Q, Liu J, Jin J, Luo J, Zeng Y, Gao S, Zhang X, Zhou X, Shi Q, Xia R, Xie X, Jiang Z, Gao L, Bai Y, Li Y, Xiong J, Li R, Zou J, Niu T, Yang R, Hu Y. A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia. J Hematol Oncol. 2021 Feb 25;14(1):37. doi: 10.1186/s13045-021-01047-9.