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

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ClinicalTrials.gov Identifier: NCT01356511
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Purpura, Thrombocytopenic, Idiopathic Drug: Prednisone Drug: Dexamethasone Phase 4

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial
Study Start Date : September 2010
Primary Completion Date : May 2014
Study Completion Date : March 2015

Arms and Interventions

Arm Intervention/treatment
Experimental: Prednisone group
Patients in the PDN arm received PDNorally at 1.0mg/kg body weight daily for 4 consecutive weeks.
Drug: Prednisone
Prednisone, po, 1 mg/kg/d, for 4 weeks.
Other Name: CD-PRE
Experimental: Dexamethasone group
DXM was administered orally at 40 mg daily for 4 consecutive days and then stopped
Drug: Dexamethasone
Dexamethasone, po, 40 mg/d, for 4 days.
Other Name: HD-DXM

Outcome Measures

Primary Outcome Measures :
  1. Proposed criteria for assessing response to ITP treatments [ Time Frame: The time frame is up to 28 days per subject ]
    1. Complete response (CR): A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding.
    2. 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.
    3. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. 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 second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
  4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  5. 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)
  6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  7. 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.
  8. Patients who are deemed unsuitable for the study by the investigator.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356511

China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China
Sponsors and Collaborators
Shandong University
Chinese Academy of Medical Sciences
Peking Union Medical College Hospital
Ruijin Hospital
Wuhan Union Hospital, China
Tongji Hospital
Shandong University of Traditional Chinese Medicine
Anhui Provincial Hospital
Zhejiang Provincial Hospital of TCM
Second Hospital of Shanxi Medical University
Xinjiang Uygur Autonomous Region People's Hospital
Shenzhen Second People's Hospital
Principal Investigator: Ming Hou, DR. Shandong University
More Information


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ming Hou, Prof, Shandong University
ClinicalTrials.gov Identifier: NCT01356511     History of Changes
Other Study ID Numbers: ITP-002
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: September 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ming Hou, Shandong University:
Purpura, Thrombocytopenic, Idiopathic

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents