Status:
UNKNOWN
The Combination of Sitagliptin and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Lead Sponsor:
Peking University People's Hospital
Conditions:
Immune Thrombocytopenia
Blood Coagulation Disorders
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Randomized, open-label, multicenter study to compare the efficacy and safety of combination of Sitagliptin and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune ...
Detailed Description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 120 adults with steroid-resistant/relapse ITP in China. Patients were randomized to Sitagliptin plus dan...
Eligibility Criteria
Inclusion
- Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia; Platelet count of less than 30×109/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; 18 years older;
Exclusion
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus) Congestive heart failure Severe arrhythmia Nursing or pregnant women Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria Creatinine or serum bilirubin levels each 1•5 times or more than the normal range Active or previous malignancy Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05353673
Start Date
June 1 2021
End Date
February 1 2023
Last Update
April 29 2022
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010