rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP

April 18, 2016 updated by: Ming Hou, Shandong University

A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 200 primary ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count was evaluated before and after treatment, in order to report the conversion ratio of primary ITP to chronic ITP.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 3

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
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital, Shandong University

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Meet the diagnostic criteria for immune thrombocytopenia.
  2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
  3. To show a platelet count < 30×10^9/L, and with bleeding manifestations.
  4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
  5. Willing and able to sign written informed consent.

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  2. Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
  3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
  5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  6. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
  7. Patients who are deemed unsuitable for the study by the investigator.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combination treatment group
100 enrolled patients are randomly picked up to take rhTPO in combination with dexamethasone at the indicated dose.
Drug: recombinant human thrombopoietin (rhTPO); dexamethasone
Patients in recombination treatment group take rhTPO( subcutaneously , 300U/kg for 14 consecutive days, followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days)
Other Names:
  • Recombinant Human Thrombopoietin
  • Recombinant Human TPO
  • rhTPO combine with Dexamethasone
  • Recombinant Human Thrombopoietin combine with Dexamethasone
  • Recombinant Human TPO combine with Dexamethasone
Active Comparator: single treatment group
100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.
Drug: Dexamethasone
Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of platelet response
Time Frame: up to 1 year per subject
Chronic ITP is defined as having platelet count less than 100×10^9/L,lasting for more than 12 months.
up to 1 year per subject
Evaluation of platelet response (R)
Time Frame: up to 1 year per subject
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
up to 1 year per subject

Collaborators and Investigators

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

Sponsor

Shandong University

Collaborators

China Medical University, China
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Shandong Provincial Hospital
Shenzhen Second People's Hospital
The First Affiliated Hospital of Dalian Medical University
Anhui Medical University
Zhejiang Provincial Hospital of TCM

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

July 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP-007

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.

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