High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Shandong University

Status and phase: Completed; Phase 4

Conditions: Purpura, Thrombocytopenic, Idiopathic

Treatments: Drug: Dexamethasone; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01356511

ITP-002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 261 patients

Sex: All

Ages: 18 to 80 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 ~ 80 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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261 participants in 2 patient groups

Prednisone group

Experimental group

Description:

Patients in the PDN arm received PDNorally at 1.0mg/kg body weight daily for 4 consecutive weeks.

Treatment:

Drug: Prednisone

Dexamethasone group

Experimental group

Description:

DXM was administered orally at 40 mg daily for 4 consecutive days and then stopped

Treatment:

Drug: Dexamethasone