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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Purpura, Thrombocytopenic, Idiopathic

Treatments: Drug: Hetrombopag Olamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02403440

TPOPId

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Hetrombopag Olamine

Experimental group

Description:

Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Treatment:

Drug: Hetrombopag Olamine