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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01356511
First received: May 17, 2011
Last updated: April 18, 2016
Last verified: September 2010
  Purpose
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 Intervention Phase
Purpura, Thrombocytopenic, Idiopathic
Drug: Prednisone
Drug: Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Proposed criteria for assessing response to ITP treatments [ Time Frame: The time frame is up to 28 days per subject ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 261
Study Start Date: September 2010
Study Completion Date: March 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01356511

Locations
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
Investigators
Principal Investigator: Ming Hou, DR. Shandong University
  More Information

Publications:

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 
Study First Received: May 17, 2011
Last Updated: April 18, 2016
Health Authority: China: Ministry of Health
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Shandong University:
Purpura, Thrombocytopenic, Idiopathic

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 21, 2016