Overview

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

Status:
Recruiting

Trial end date:
2023-02-01

Target enrollment:
0

Participant gender:
All

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 thrombocytopenia (ITP).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Peking University People's Hospital

Treatments:

Danazol
Sitagliptin Phosphate

Criteria

Inclusion Criteria:

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 Criteria:

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.