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

Last updated: July 20, 2022
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Platelet Disorders

White Cell Disorders

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT05471050
PKU-ITP036
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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-dosecorticosteroids for a minimum duration of 4 weeks or who relapsed duringsteroid-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 hadbeen stable in the past month and the dose was expected to be stable after enrolmentand remained unchanged at least for the first 4 weeks of study until initial responsewas assessed, unless severe adverse events were suspected.

Exclusion

Exclusion Criteria:

  • Secondary ITP (e.g., patients with HIV, HBV, HCV, Helicobacter pylori infection orSLE);
  • 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 insufficienttime.

Study Design

Total Participants: 120
Study Start date:
March 02, 2022
Estimated Completion Date:
June 01, 2023

Study 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.

Connect with a study center

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

    Beijing, Beijing 100010
    China

    Active - Recruiting

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