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

• Status: Not yet recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).

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

Details

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

Criteria

Inclusion Criteria: Patients >18 years old with corticosteroid-resistant or relapsed ITP who had either a platelet count of <30×10^9/L or a platelet count of <50×10^9/L and clinically significant bleeding.

1. Not achieving a sustained response to therapy with full-dose corticosteroids for a duration of at least 4 weeks or relapsed during the process of corticosteroid tapering or discontinuation;

2. Platelet counts <30×10^9/L or platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

3. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;

2. Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);

3. Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);

4. Severe medical condition (lung, heart, hepatic or renal disorder);

5. Patients who are deemed unsuitable for the study by the investigator.

6. Patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.