Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)

Shandong University

Status and phase: Withdrawn; Phase 4

Conditions: Immune Thrombocytopenia

Treatments: Drug: Dexamethasone (4 cycles); Drug: Dexamethasone (1 cycle)

Study type: Interventional

Funder types: Other

Identifiers

NCT02642380

High-dose dexamethasone

Details and patient eligibility

About

The project was organized by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of different cycles of high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Full description

The investigators are undertaking a multicenter, randomized, controlled trial of 200 primary ITP adult patients from 11 medical centers in China. One part of the participants are randomly selected to receive four cycles of high-dose dexamethasone (given orally at a dose of 40mg per day for 4 consecutive days every 14 days for 4 cycles), comparing the others with one cycle (given orally at a dose of 40 mg per day for 4 consecutive 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 cycles of high-dose dexamethasone therapy for the treatment of adults with ITP.

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 ~ 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)

---

0 participants in 2 patient groups

4 cycles

Experimental group

Description:

Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses

Treatment:

Drug: Dexamethasone (4 cycles)

1 cycle

Active Comparator group

Description:

Oral administration of dexamethasone 40 mg for four consecutive days

Treatment:

Drug: Dexamethasone (1 cycle)