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NCT Number: NCT02153060

An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)

The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known hospitals in China. In order to report the efficacy and safety of different dose dexamethasone in treating the immune thrombocytopenia (ITP).

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Key information

Conditions

Immune Thrombocytopenia 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 Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 adults with ITP from 7 medical centers in China. Part of the participants are randomly selected to receive dexamethasone (given at a dose of 40mg per day for 4 consecutive days) ,the others are selected to receive dexamethasone(given at a dose of 20 mg daily for 4 days).

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 different dose dexamethasone for the treatment of adults with immune thrombocytopenia (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 ~ 75 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

Dexamethasone

Drug

Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days

Primary outcomes

  1. Proposed criteria for assessing early response to ITP treatments

    Time frame: 3 months

    • 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.

Secondary outcomes

  1. Safety

    Time frame: 1 years

    The type and frequency of therapy associated adverse events

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Anhui Provincial Hospital
  • Chinese Academy of Medical Sciences
  • Peking Union Medical College Hospital
  • Second Hospital of Shanxi Medical University
  • Shandong Provincial Hospital
  • Shandong University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Dalian Medical University

Registry information

Official study title

A Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Different Doses of Dexamethasone for Management of Immune Thrombocytopenia (ITP)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2014
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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