A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura

Conditions
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Purpura, Thrombocytopenic, Idiopathic

Intervention / Treatment
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* Drug: Hetrombopag Olamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hetrombopag Olamine<br>Hetrombopag Olamine 2.5mg, 5mg and 7.5mg | Drug: Hetrombopag Olamine<br>* Hetrombopag Olamine 2.5mg, 5mg and 7.5mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of volunteers with adverse events as a measure of safety and tolerability |  | up to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic (PK) parameters of Hetrombopag after multiple dose from day 1 to day 14, composite including AUC, Cmax, Tmax, and t1/2 |  | day 1 and day 14 | 
| The proportion of patients with platelet counts ≥50,000/µL after treatment |  | up to Day 28 |