Back to resultsA Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
Primary Purpose
Purpura, Thrombocytopenic, Idiopathic
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Hetrombopag Olamine
Sponsored by
About this trial
This is an interventional treatment trial for Purpura, Thrombocytopenic, Idiopathic
Eligibility Criteria
Inclusion Criteria:
- Chronical ITP patients.
- The subjects were diagnosed as ITP with bone marrow aspiration within 3 months before enrollment or in the screening period. And secondary immune thrombocytopenia (e.g., myelodysplastic syndrome, systemic lupus erythematosus, aplastic anemia) was excluded.
- Patients had a mean platelet count of less than 30,000/µL in the screening period.
- Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
- Patients receiving danazol, mycophenolate mofetil or cyclosporine A must have received a stable dose for at least 12 weeks.
- Normal PT/INR and APTT.
Exclusion Criteria:
- Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis.
- Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
- Malignant disease
- Cancer treatment with cytotoxic chemotherapy and/or radiotherapy.
Patients with one of the following conditions should be excluded:
- Treatment with immunoglobulins within 1 week preceding the first dose of study medication.
- Treatment with splenectomy or rituximab within 12 weeks preceding the first dose of study medication.
- Treatment with eltrombopag or Nplate within 4 weeks preceding the first dose of study medication.
- Treatment with cyclophosphamide or vinca alkaloids within 4 weeks preceding the first dose of study medication.
- ALT>2×ULN，AST>2×ULN，Total Bilirubin>1.5×ULN，serum creatinine >1.2×ULN，Total albumin <0.9×LLN
Sites / Locations
- West Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hetrombopag Olamine
Arm Description
Hetrombopag Olamine 2.5mg, 5mg and 7.5mg
Outcomes
Primary Outcome Measures
The number of volunteers with adverse events as a measure of safety and tolerability
Secondary Outcome Measures
Plasma pharmacokinetic (PK) parameters of Hetrombopag after multiple dose from day 1 to day 14, composite including AUC, Cmax, Tmax, and t1/2
The proportion of patients with platelet counts ≥50,000/µL after treatment
Full Information
NCT ID
NCT02403440
First Posted
March 20, 2015
Last Updated
March 30, 2015
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02403440
Brief Title
A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
Official Title
A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopenic, Idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hetrombopag Olamine
Arm Type
Experimental
Arm Description
Hetrombopag Olamine 2.5mg, 5mg and 7.5mg
Intervention Type
Drug
Intervention Name(s)
Hetrombopag Olamine
Intervention Description
Hetrombopag Olamine 2.5mg, 5mg and 7.5mg
Primary Outcome Measure Information:
Title
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame
up to Day 28
Secondary Outcome Measure Information:
Title
Plasma pharmacokinetic (PK) parameters of Hetrombopag after multiple dose from day 1 to day 14, composite including AUC, Cmax, Tmax, and t1/2
Time Frame
day 1 and day 14
Title
The proportion of patients with platelet counts ≥50,000/µL after treatment
Time Frame
up to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronical ITP patients.
The subjects were diagnosed as ITP with bone marrow aspiration within 3 months before enrollment or in the screening period. And secondary immune thrombocytopenia (e.g., myelodysplastic syndrome, systemic lupus erythematosus, aplastic anemia) was excluded.
Patients had a mean platelet count of less than 30,000/µL in the screening period.
Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
Patients receiving danazol, mycophenolate mofetil or cyclosporine A must have received a stable dose for at least 12 weeks.
Normal PT/INR and APTT.
Exclusion Criteria:
Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis.
Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
Malignant disease
Cancer treatment with cytotoxic chemotherapy and/or radiotherapy.
Patients with one of the following conditions should be excluded:
Treatment with immunoglobulins within 1 week preceding the first dose of study medication.
Treatment with splenectomy or rituximab within 12 weeks preceding the first dose of study medication.
Treatment with eltrombopag or Nplate within 4 weeks preceding the first dose of study medication.
Treatment with cyclophosphamide or vinca alkaloids within 4 weeks preceding the first dose of study medication.
ALT>2×ULN，AST>2×ULN，Total Bilirubin>1.5×ULN，serum creatinine >1.2×ULN，Total albumin <0.9×LLN
Facility Information:
Facility Name
West Hospital, Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Maozhi
Email
tayler22@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32865293
Citation
Wang Z, Chen L, Zhang F, Lu H, Chen X, Wen A, Luo J, Hu Y, Wang Y, Niu T, Zheng L. First-in-patient study of hetrombopag in patients with chronic idiopathic thrombocytopenic purpura. J Thromb Haemost. 2020 Nov;18(11):3053-3060. doi: 10.1111/jth.15078. Epub 2020 Oct 1.
Results Reference
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A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
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