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

NCT ID: NCT02403440

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30

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.

Conditions

Purpura, Thrombocytopenic, Idiopathic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hetrombopag Olamine

Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Group Type: EXPERIMENTAL

Hetrombopag Olamine

Intervention Type: DRUG

Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Interventions

Hetrombopag Olamine

Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West Hospital, Sichuan University

Chengdu, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Liang Maozhi

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32865293 (View on PubMed)

Other Identifiers

TPOPId

Identifier Type: -

Identifier Source: org_study_id