Back to resultsHigh-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
Primary Purpose
Purpura, Thrombocytopenic, Idiopathic
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Prednisone
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Purpura, Thrombocytopenic, Idiopathic focused on measuring Purpura, Thrombocytopenic, Idiopathic
Eligibility Criteria
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.
Sites / Locations
- Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prednisone group
Dexamethasone group
Arm Description
Patients in the PDN arm received PDNorally at 1.0mg/kg body weight daily for 4 consecutive weeks.
DXM was administered orally at 40 mg daily for 4 consecutive days and then stopped
Outcomes
Primary Outcome Measures
Proposed criteria for assessing response to ITP treatments
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 Outcome Measures
Full Information
NCT ID
NCT01356511
First Posted
May 17, 2011
Last Updated
April 18, 2016
Sponsor
Shandong University
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, People's Hospital of Xinjiang Uygur Autonomous Region, Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01356511
Brief Title
High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
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, People's Hospital of Xinjiang Uygur Autonomous Region, Shenzhen Second People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopenic, Idiopathic
Keywords
Purpura, Thrombocytopenic, Idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone group
Arm Type
Experimental
Arm Description
Patients in the PDN arm received PDNorally at 1.0mg/kg body weight daily for 4 consecutive weeks.
Arm Title
Dexamethasone group
Arm Type
Experimental
Arm Description
DXM was administered orally at 40 mg daily for 4 consecutive days and then stopped
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
CD-PRE
Intervention Description
Prednisone, po, 1 mg/kg/d, for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
HD-DXM
Intervention Description
Dexamethasone, po, 40 mg/d, for 4 days.
Primary Outcome Measure Information:
Title
Proposed criteria for assessing response to ITP treatments
Description
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.
Time Frame
The time frame is up to 28 days per subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou, DR.
Organizational Affiliation
Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19846889
Citation
Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.
Results Reference
background
PubMed Identifier
19005182
Citation
Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.
Results Reference
background
PubMed Identifier
12944568
Citation
Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.
Results Reference
background
PubMed Identifier
17077333
Citation
Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. doi: 10.1182/blood-2005-12-015222. Epub 2006 Oct 31.
Results Reference
background
PubMed Identifier
26480931
Citation
Wei Y, Ji XB, Wang YW, Wang JX, Yang EQ, Wang ZC, Sang YQ, Bi ZM, Ren CA, Zhou F, Liu GQ, Peng J, Hou M. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016 Jan 21;127(3):296-302; quiz 370. doi: 10.1182/blood-2015-07-659656. Epub 2015 Oct 19.
Results Reference
derived
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High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
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