Trial record 18 of 161 for:
Open Studies | "Blood Platelet Disorders"
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
Recruitment status was Recruiting
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
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
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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:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
MedlinePlus related topics:
Steroids
Drug Information available for:
Dexamethasone
Prednisone
Dexamethasone acetate
Dexamethasone sodium phosphate
U.S. FDA Resources
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 ]
- 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.
| 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:
- 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.
Contacts and Locations
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:
|
Blood Platelet Disorders Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia 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 May 22, 2013