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/AClinical Study ID
NCT05471050
PKU-ITP036
Ages 18-70 All Genders
Study Summary
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
Connect with a study center
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing 100010
ChinaActive - Recruiting
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