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

Shandong University

Status and phase: Completed; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02153060

ITP-Dexamethasone

Details and patient eligibility

About

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).

Full 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).

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

20mg dexamethasone group

Experimental group

Description:

Dexamethasone 20 mg per day, 4 consecutive days

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

40mg dexamethasone group

Experimental group

Description:

Dexamethasone 40 mg per day, 4 consecutive days

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone