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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Shandong University.
Recruitment status was  Recruiting
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
Chinese Traditional Medicine Hospital of Zhejiang Province
Second Affiliated Hospital of Shanxi Medical University
Xinjiang Uygur Autonomous Region People's Hospital
Shenzhen Second People's Hospital
Information provided by:
Shandong University
ClinicalTrials.gov Identifier:
NCT01356511
First received: May 17, 2011
Last updated: May 19, 2011
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
Purpura, Thrombocytopenic, Idiopathic
Drug: Conventional-dose prednisone group
Drug: High-dose dexamethasone group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.


Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional dose of prednisone group Drug: Conventional-dose prednisone group
Prednisone, po, 1 mg/kg/d, for 4 weeks.
Other Name: CD-PRE
Experimental: High-dose dexamethasone group Drug: High-dose dexamethasone group
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Ming Hou, DR. +86-531-82169114 ext 9879 houming@medmail.com.cn
Contact: Jun Peng, DR. +86-531-82169114 ext 9867 junpeng88@sina.com.cn

Locations
China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China
Contact: Ming Hou, Dr.    +86-531-82169114 ext 9879    houming@medmail.com.cn   
Principal Investigator: Ming Hou, Dr.         
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
Chinese Traditional Medicine Hospital of Zhejiang Province
Second Affiliated 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:

Responsible Party: Hou Ming/Professor and Director, Department of Hematology, Shandong University Qilu Hospital
ClinicalTrials.gov Identifier: NCT01356511     History of Changes
Other Study ID Numbers: ITP-002
Study First Received: May 17, 2011
Last Updated: May 19, 2011
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Purpura, Thrombocytopenic, Idiopathic

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

ClinicalTrials.gov processed this record on July 26, 2014