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

Sponsor

Shandong University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02642380

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia	Drug: Dexamethasone (4 cycles) Drug: Dexamethasone (1 cycle)	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4 cycles Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses	Drug: Dexamethasone (4 cycles) dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses Other Names: DXM 4
Active Comparator: 1 cycle Oral administration of dexamethasone 40 mg for four consecutive days	Drug: Dexamethasone (1 cycle) dexamethasone 40mg daily for 4 consecutive days Other Names: DXM 1

Arm

Intervention/Treatment

Experimental: 4 cycles

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

Drug: Dexamethasone (4 cycles)

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

Other Names:

DXM 4

Active Comparator: 1 cycle

Oral administration of dexamethasone 40 mg for four consecutive days

Drug: Dexamethasone (1 cycle)

dexamethasone 40mg daily for 4 consecutive days

Other Names:

DXM 1

Outcome Measures

Primary Outcome Measures

sustained response to treatment [6 months after treatment started]
percentage of patients maintaining PLT count over 30*10^9 without bleeding

Secondary Outcome Measures

Evaluation of early response [2 months after treatment started]
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.

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 ~ 80 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.