Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

Idiopathic Thrombocytopenic Purpura Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222843
• Other study ID #: HR-TPO-III-ITP
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2017
• Est. completion date: January 7, 2021

Study information

• Verified date: July 2017
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: January 7, 2021
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Hetrombopag Olamine
once daily
• matching placebo
once daily

Locations

Country	Name	City	State
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Hospital of Blood Diseases, Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients with a platelet count =50×109/L after Day 57.		Baseline to Week 8