Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Thrombocytopenia Clinical Trial

Official title: Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Status Recruiting

Clinical Trial Summary

Proportion who would avoid splenectomy at 6 months of follow up

Clinical Trial Description

1. If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week.

Second line Helicobacter pylori eradication will be permitted after failure of first line treatment.

2. Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)

3. Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

• NCT number: NCT01162941
• Study type: Interventional
• Source: Cooperative Study Group A for Hematology
• Contact: Sung-Hwa Bae, professor
• Phone: 82-53-650-4388
• Email: sunghwa@cu.ac.kr
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2010
• Completion date: January 2012