Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
26 participants
OBSERVATIONAL
2010-09-30
2012-08-31
Brief Summary
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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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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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C13-urea breath test: positive
lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
55 Years
ALL
No
Sponsors
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Cooperative Study Group A for Hematology
NETWORK
Responsible Party
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Cooperative Study Group A for Hematology
Principal Investigators
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Jung-Hee Lee, professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Hyo Jung Kim, professor
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Hallym University Sacred Heart Hospital
Locations
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Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Yae-Eun Jang, nurse
Role: primary
References
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Kim H, Lee WS, Lee KH, Bae SH, Kim MK, Joo YD, Zang DY, Jo JC, Lee SM, Lee JH, Lee JH, Kim DY, Ryoo HM, Hyun MS, Kim HJ; CoOperative Study Group A for Hematology (COSAH). Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia. Ann Hematol. 2015 May;94(5):739-46. doi: 10.1007/s00277-014-2268-9. Epub 2014 Dec 13.
Related Links
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Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP)
Other Identifiers
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C-023
Identifier Type: -
Identifier Source: org_study_id