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Completed

NCT Number: NCT01356511

High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

The project was undertaking by Qilu Hospital of Shandong University and other 11 well-known hospitals in China. In order to report the efficacy and safety of high-dose dexamethasone compared to conventional dose prednisone for the first-line treatment of adults with primary immune thrombocytopenia(ITP).

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Key information

Conditions

Purpura, Thrombocytopenic, Idiopathic Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Qilu Hospital, Shandong University

Jinan, Shandong, China

About this study

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 300 adults with ITP from 11 medical centers in China. Part of the participants are randomly selected to receive high-dose dexamethasone treatment and the other part are selected to receive conventional dose of prednisone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of high-dose dexamethasone compared to conventional dose prednisone for the first-line treatment of adults with ITP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria for immune thrombocytopenia.
  • Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
  • To show a platelet count <30 * 10^9/L, and with bleeding manifestations.
  • Willing and able to sign written informed consent.

Exclusion criteria

  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  • Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  • Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
  • Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  • Severe medical condition (lung, hepatic or renal disorder) other than chronic 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)
  • Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  • 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.
  • Patients who are deemed unsuitable for the study by the investigator.

Treatment and study plan

Prednisone

Drug

Prednisone, po, 1 mg/kg/d, for 4 weeks.

Other names: CD-PRE

Dexamethasone

Drug

Dexamethasone, po, 40 mg/d, for 4 days.

Other names: HD-DXM

Primary outcomes

  1. Proposed criteria for assessing response to ITP treatments

    Time frame: The time frame is up to 28 days per subject

    • Complete response (CR)： A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding.
    • Response (R)： A platelet count ≥ 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding.
    • No response (NR)： A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Anhui Provincial Hospital
  • Chinese Academy of Medical Sciences
  • Peking Union Medical College Hospital
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Ruijin Hospital
  • Second Hospital of Shanxi Medical University
  • Shandong University of Traditional Chinese Medicine
  • Shenzhen Second People's Hospital
  • Tongji Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Zhejiang Provincial Hospital of TCM

Registry information

Official study title

High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
May 19, 2011
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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