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

A Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Different Doses of Dexamethasone for Management of Immune Thrombocytopenia (ITP)

Sponsors

Lead Sponsor: Shandong University

Collaborator: 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

Source 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).

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).

Overall Status Completed
Start Date May 2014
Completion Date August 2015
Primary Completion Date January 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proposed criteria for assessing early response to ITP treatments 3 months
Secondary Outcome
Measure Time Frame
Safety 1 years
Enrollment 58
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days

Arm Group Label: 40mg dexamethasone group

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days

Arm Group Label: 20mg dexamethasone group

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ming Hou, DR. Principal Investigator Shandong University
Location
Facility: Qilu Hospital, Shandong University
Location Countries

China

Verification Date

May 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Professor and Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 20mg dexamethasone group

Type: Experimental

Description: Dexamethasone 20 mg per day, 4 consecutive days

Label: 40mg dexamethasone group

Type: Experimental

Description: Dexamethasone 40 mg per day, 4 consecutive days

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov