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

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ClinicalTrials.gov Identifier: NCT03222843
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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
Idiopathic Thrombocytopenic Purpura Drug: Hetrombopag Olamine Drug: matching placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020


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




Primary Outcome Measures :
  1. the proportion of patients with a platelet count ≥50×109/L after Day 57. [ Time Frame: Baseline to Week 8 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222843


Locations
China, Hubei
Union Hospital Tongji Medical College Huazhong University of Science and technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Yu Hu, Ph.D       dr_huyu@126.com   
Contact: Heng Mei, Ph.D       mayheng@126.com   
China, Sichuan
West China Hospital,Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Ting Niu, MD       tingniu@sina.com   
China, Tianjin
Hospital of Blood Diseases, Chinese Academy of Medical Sciences Recruiting
Tianjin, Tianjin, China, 300041
Contact: Renchi Yang, MD       rcyang65@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03222843     History of Changes
Other Study ID Numbers: HR-TPO-III-ITP
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
ITP

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases