Efficacy of Helicobacter pylori Eradication for the Treatment of Immune Thrombocytopenic Purpura (ITP)

Not Applicable

Recruiting

Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

Registration Number: KCT0003270

Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

•Age = 19 years
•Persistent or chronic ITP patients defined by international working group
•30 X 10^9/L = platelet level = 80 X 10^9/L
•H. pylori infection should be confirmed by at least one of tests: urea breath test (UBT), CLO, stool H. pylori Ag, H. pylori in gastric tissue (reported by a trained pathologist)
•No history of any ITP treatment for the past 3 months
•No previous history of H. pylori eradication treatment
•Patients who voluntarily participate in this study and with informed consents

Exclusion Criteria

•patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, malignant neoplasm, liver disease, definite SLE and other autoimmune diseases, drugs, MDS and leukemia
•uncontrolled hypothyroidism or hyperthyroidism
•active bleeding for the past 3 months or history of hemorrhagic gastric ulcer or brain hemorrhage
•active infection
•patients who are taking anticoagulant or aspirin
•patients with penicillin allergy or side effects of macrolide
•patients who are taking mizolastine, terfenadine, cisapride, pimozide, astemizole, ergot alkaloid and its derivatives (ergotamine and dihydroergotamine), bepridil or atazanavir
•patients who have known allergy or severe side effect on study drugs
•pregnant or lactating women

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall response rate (complete response + response rate) of platelets

Secondary Outcome Measures

Name	Time	Method
Overall response rate between treatment group and control group at 3 months after randomization;Overall response rate of control group who treated with H. pylori eradication, at 3 months after treatment;Time to response;Response duration;drug toxicity, safety and compliance;H. pylori eradication rate;Quality of life after H. pylori eradication;clinical characteristics between groups