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

Sponsor

Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT02153060

Collaborator

Chinese Academy of Medical Sciences (Other), Shandong Provincial Hospital (Other), The First Affiliated Hospital of Dalian Medical University (Other), Peking Union Medical College Hospital (Other), Shandong University of Traditional Chinese Medicine (Other), Anhui Provincial Hospital (Other), Second Hospital of Shanxi Medical University (Other)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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 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).

Study Design

Study Type:

Interventional

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 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proposed criteria for assessing early response to ITP treatments [3 months]
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

Safety [1 years]
The type and frequency of therapy associated adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia
Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 75 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