The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroidresistant/relapsed ITP.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Acetylcysteine; Atorvastatin; Atorvastatin Calcium; Danazol; N-monoacetylcystine

Criteria

Inclusion Criteria:

• ITP confirmed by excluding other supervened causes of thrombocytopenia;

• Platelet count of less than 30×10^9/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;

• ECOG<2.

• EPCs in bone marrow less than 0.02%

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.