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

Peking University

Status and phase: Enrolling; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Drug: TAC; Drug: Danazol

Study type: Interventional

Funder types: Other

Identifiers

NCT05471050

PKU-ITP036

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

tacrolimus and Danazol

Experimental group

Description:

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.

Treatment:

Drug: Danazol

Drug: TAC

Danazol

Active Comparator group

Description:

Danazol is given at 200mg bid for 12 weeks.

Treatment:

Drug: Danazol