The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

NCT ID: NCT05471050

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2023-06-01

Brief Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of tacrolimus and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

Detailed Description

The investigators are undertaking a randomized controlled trial of 120 adults with steroid-resistant/relapse ITP in China. Patients were randomized to tacrolimus plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

Immune Thrombocytopenia

Study Design

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

Study Groups

tacrolimus and Danazol

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

TAC

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.

Danazol

Intervention Type: DRUG

Danazol is given at 200mg bid for 12 weeks.

Danazol

Danazol is given at 200mg bid for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Danazol

Intervention Type: DRUG

Danazol is given at 200mg bid for 12 weeks.

Interventions

TAC

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

Danazol

Danazol is given at 200mg bid for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Primary immune thrombocytopenia (ITP);
• 18 years older;
• Platelet count of less than 30×10^9/L at enrollment;
• Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
• Patients who were receiving other maintenance regimens, primarily corticosteroids, ciclosporin, or mycophenolate mofetil, were also eligible if the dose of treatment had been stable in the past month and the dose was expected to be stable after enrolment and remained unchanged at least for the first 4 weeks of study until initial response was assessed, unless severe adverse events were suspected.

Exclusion Criteria

• Secondary ITP (e.g., patients with HIV, HBV, HCV, Helicobacter pylori infection or SLE);
• Congestive heart failure, severe arrhythmia;
• Nursing or pregnant women;
• ALT or AST levels ≥ 3× the upper limit of the normal threshold;
• Creatinine or serum bilirubin levels ≥ 1.5× the upper limit;
• Active or previous malignancy ;
• Patients who had received danazol treatment or did not respond to danazol;
• Patients unable to have routine blood tests because of reasons such as insufficient time.

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

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice president of Peking Univeristy Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao-Hui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital, Peking University Insititute of Hematology

Locations

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao-Hui Zhang, MD

Role: CONTACT

zhangxh@bjmu.edu.cn

+8613522338836

Xuan Cai, MD

Role: CONTACT

2206385254@qq.com

+8618811729606

Facility Contacts

Xiao-hui Zhang, MD

Role: primary

zhangxh@bjmu.edu.cn

+8613522338836

Other Identifiers

PKU-ITP036

Identifier Type: -

Identifier Source: org_study_id