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

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of iguratimod and danazol versus danazol for the treatment of adults with steroid-resistant/ relapse immune thrombocytopenia (ITP).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Beijing Friendship Hospital; Beijing Hospital; China-Japan Friendship Hospital; First Affiliated Hospital of Chongqing Medical University; Shanxi Bethune Hospital; The First Affiliated Hospital of Zhengzhou University
• Treatments: Danazol

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.