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

Phase 1

• Conditions: Purpura, Thrombocytopenic, Idiopathic
• Interventions: Drug: Hetrombopag Olamine

• Registration Number: NCT02403440
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Status Verified: 2015-03
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-30
• Last Update Submitted: 2015-03-30
• Study First Posted: 2015-03-31
• Last Update Posted: 2015-03-31
• Primary Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hetrombopag Olamine	Hetrombopag Olamine	Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Primary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 28

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West Hospital, Sichuan University; 🇨🇳 Chengdu, China