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

March 30, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China
        • Recruiting
        • West Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hetrombopag Olamine
Hetrombopag Olamine 2.5mg, 5mg and 7.5mg
Drug: Hetrombopag Olamine
Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: day 1 and day 14
day 1 and day 14
The proportion of patients with platelet counts ≥50,000/µL after treatment
Time Frame: up to Day 28
up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPOPId

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Purpura, Thrombocytopenic, Idiopathic

Clinical Trials on Hetrombopag Olamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe