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

Last updated: April 18, 2016
Sponsor: Shandong University
Overall Status: Trial Not Available

Phase

3

Condition

Lupus

Anemia

Immune Thrombocytopenia (Itp)

Treatment

N/A

Clinical Study ID

NCT01734057
ITP-008
  • Ages 18-75
  • All Genders

Study Summary

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 Rituximab for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meet the diagnostic criteria for immune thrombocytopenia.

  2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80years.

  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

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet countswithin 3 months before the screening visit.

  2. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3weeks 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 oruncontrolled disease or condition related to or impacting cardiac function (e.g.,unstable angina, congestive heart failure, uncontrolled hypertension or cardiacarrhythmia)

  5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplatepregnancy during the study period.

  6. Have a known diagnosis of other autoimmune diseases, established in the medicalhistory and laboratory findings with positive results for the determination ofantinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or directCoombs test.

  7. Patients who are deemed unsuitable for the study by the investigator.

Study Design

Study Start date:
July 01, 2012
Estimated Completion Date:
October 31, 2013

Study Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 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/kgfor 14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; 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.

Connect with a study center

  • Qilu Hospital, Shandong University

    Jinan, Shandong
    China

    Site Not Available

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