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An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)

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ClinicalTrials.gov Identifier: NCT02153060
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 20, 2016
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences
Shandong Provincial Hospital
The First Affiliated Hospital of Dalian Medical University
Peking Union Medical College Hospital
Shandong University of Traditional Chinese Medicine
Anhui Provincial Hospital
Second Hospital of Shanxi Medical University
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known hospitals in China. In order to report the efficacy and safety of different dose dexamethasone in treating the immune thrombocytopenia (ITP).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Dexamethasone Phase 2

Detailed Description:

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 adults with ITP from 7 medical centers in China. Part of the participants are randomly selected to receive dexamethasone (given at a dose of 40mg per day for 4 consecutive days) ,the others are selected to receive dexamethasone(given at a dose of 20 mg daily for 4 days).

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 different dose dexamethasone for the treatment of adults with immune thrombocytopenia (ITP).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Different Doses of Dexamethasone for Management of Immune Thrombocytopenia (ITP)
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: 20mg dexamethasone group
Dexamethasone 20 mg per day, 4 consecutive days
Drug: Dexamethasone
Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days

Experimental: 40mg dexamethasone group
Dexamethasone 40 mg per day, 4 consecutive days
Drug: Dexamethasone
Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days




Primary Outcome Measures :
  1. Proposed criteria for assessing early response to ITP treatments [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Safety [ Time Frame: 1 years ]
    The type and frequency of therapy associated adverse events



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 ~ 75 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

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): NCT02153060


Locations
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China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Chinese Academy of Medical Sciences
Shandong Provincial Hospital
The First Affiliated Hospital of Dalian Medical University
Peking Union Medical College Hospital
Shandong University of Traditional Chinese Medicine
Anhui Provincial Hospital
Second Hospital of Shanxi Medical University
Investigators
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Principal Investigator: Ming Hou, DR. Shandong University

Publications:
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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT02153060     History of Changes
Other Study ID Numbers: ITP-Dexamethasone
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: May 2014
Keywords provided by Ming Hou, Shandong University:
immune thrombocytopenia
dexamethasone
efficacy
safety
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
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
Antineoplastic Agents
Protease Inhibitors