The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

NCT ID: NCT04747080

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-07-01

Brief Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of Combination of High-dose Dexamethasone and Tacrolimus versus High-dose Dexamethasone for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Detailed Description

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with ITP in China. Patients were randomized to tacrolimuis plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

ITP; Immune Thrombocytopenia

Study Design

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

Study Groups

TAC and HD-DXM

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).

Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).

Tacrolimus

Intervention Type: DRUG

Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.

HD-DXM

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14) .

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).

Interventions

Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).

Intervention Type: DRUG

Tacrolimus

Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

HD-DXM; High-dose Dexamethasone; TAC

Eligibility Criteria

Inclusion Criteria

1. Confirmed newly-diagnosed, treatment-naive ITP;

2. Platelet counts <30×109/L ;

3. Platelet counts < 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

4. Willing and able to sign written informed consent.

Exclusion Criteria

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;

2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;

3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;

4. Active infection;

5. Maligancy;

6. 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);

7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy

8. 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;

9. Patients who are deemed unsuitable for the study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice President of Peking University Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhuo-Yu Zhang, doctor

Role: primary

zhangxh100@sina.com

+8615010638916

Zhuo Yu An, doctor

Role: backup

anzhuoyu@pku.edu.cn

+8615010638916

Other Identifiers

ITP-PKU022

Identifier Type: -

Identifier Source: org_study_id