The Combination of ATRA and Danazol as Second-line Treatment in Adult Immune Thrombocytopenia

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, open-label, multicentre study to compare the efficacy and safety of ATRA plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.

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

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Beijing Hospital; Beijing Municipal Science & Technology Commission; Beijing Tongren Hospital; Navy General Hospital, Beijing; Qilu Hospital of Shandong University
• Treatments: Danazol; Tretinoin

Criteria

Inclusion Criteria:

• Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;

• Platelet count of less than 30×109/L at enrolment

• 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.