Status:
UNKNOWN
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 firs...
Eligibility Criteria
Inclusion
- ITP is defined by
- (a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia
- Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)
- 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)
- 18 years old or more
Exclusion
- Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug
- Pregnancy
- Splectomized patients
- Rh- blood type
- Hemoglobin \< 10g/dL
- Known hypersensitivity to immunoglobulins
- A positive direct antiglobulin test
- Clinically relevant hepatic or renal disease
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01162941
Start Date
February 1 2010
End Date
January 1 2012
Last Update
July 15 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea, 138-736