NCT01162941

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Cooperative Study Group A for Hematology · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Proportion who would avoid splenectomy at 6 months of follow up

Detailed 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.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
OTHER	Steroid refractory ITP	a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-07-01
• Completion: 2012-01-01
• First posted: 2010-07-15
• Last updated: 2010-07-15

Locations

1 site across 1 country: South Korea