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

• Status: Recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Single-arm, open-label, single center study to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid resistant/relapsed ITP.

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

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Danazol; Terbutaline

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;

• Subject has signed and dated written informed consent.

• Fertile patients must use effective contraception during treatment and observational period

• Negative pregnancy test.

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.

• diagnosis with any of the following diseases: chronic hypertension, hyperthyroidism, diabetes, or seizure disorder.