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

NCT ID: NCT02642380

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-11-30

Brief Summary

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).

Detailed 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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

4 cycles

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

Group Type: EXPERIMENTAL

Dexamethasone (4 cycles)

Intervention Type: DRUG

dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses

1 cycle

Oral administration of dexamethasone 40 mg for four consecutive days

Group Type: ACTIVE_COMPARATOR

Dexamethasone (1 cycle)

Intervention Type: DRUG

dexamethasone 40mg daily for 4 consecutive days

Interventions

Dexamethasone (4 cycles)

dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses

Intervention Type: DRUG

Dexamethasone (1 cycle)

dexamethasone 40mg daily for 4 consecutive days

Intervention Type: DRUG

Other Intervention Names

DXM 4; DXM 1

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 ~ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong University Qilu Hospital

Locations

Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

High-dose dexamethasone

Identifier Type: -

Identifier Source: org_study_id