Helicobacter Pylori Immune Thrombocytopenic Purpura

Study Overview
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Brief Summary
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We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. If this eradication treatment is revealed effective on ITP patients with more than 30X109/L of platelet, it would be valuable treatment especially for young ITP patients with mild to moderate thrombocytopenia.

Detailed Description
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lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days. (Jeil Pharm. CO. LTD. will provide lansoprazole.) C13-UBT, at 4 weeks after onset of treatment, to determine eradication

Official Title
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Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia

Conditions
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Immune Thrombocytopenic Purpura

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 55 years old Persistent or chronic ITP patients, defined by international working group ( persistent: between 3 to 12 months from diagnosis, chronic: lasting for more than 12 months) 30X109/L ≤ platelet count ≤ 70X109/L C13-urea breath test: positive no previous ITP treatment no previous H. pylori eradication treatment Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: Patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, liver disease, definite SLE, drug, MDS, leukemia Uncontrolled hypothyroidism or hyperthyroidism Acute active bleeding or infection Who taking anti-coagulant or aspirin Patients with penicillin allergy Patients with side effects of macrolide. Patients who taking Mizolastine, Terfenadine, Cisapride, Pimozide, Astemizole, Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine), Bepridil, or Atazanavir Patients who have known allergy or severe side effect on study drugs Pregnant or lactating women Clinically relevant hepatic or renal disease (Creatinine clearance ≤ 30mL/min) patients who cannot understand informed consent or express his/her condition

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C13-urea breath test: positive<br>lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response | Overall response rate at 3 months after treatment | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of H. pylori | We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. Duration of response Side effect and safety of treatment | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITP