Purpura, Thrombocytopenic, Idiopathic
Conditions
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.
Interventions
Hetrombopag Olamine 2.5mg, 5mg and 7.5mg
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Chronical ITP patients. 2. 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. 3. Patients had a mean platelet count of less than 30,000/µL in the screening period. 4. Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month. 5. Patients receiving danazol, mycophenolate mofetil or cyclosporine A must have received a stable dose for at least 12 weeks. 6. Normal PT/INR and APTT.
Exclusion criteria
1. 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. 2. 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). 3. Malignant disease 4. Cancer treatment with cytotoxic chemotherapy and/or radiotherapy. 5. 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. 6. ALT\>2×ULN，AST\>2×ULN，Total Bilirubin\>1.5×ULN，serum creatinine \>1.2×ULN，Total albumin \<0.9×LLN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 28 |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed