Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01255332
Status:
UNKNOWN
Last Update Posted:
2010-12-07
First Post:
2010-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Immune Thrombocytopenic Purpura
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2010-11-24', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response', 'timeFrame': '2 years', 'description': 'Overall response rate at 3 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Eradication rate of H. pylori', 'timeFrame': '2 years', 'description': '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.\n\n* Duration of response\n* Side effect and safety of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ITP'], 'conditions': ['Immune Thrombocytopenic Purpura']}, 'referencesModule': {'references': [{'pmid': '25501820', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.google.co.kr', 'label': 'Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIf 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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'immune thrombocytopenic purpura', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20\\~55 years old\n* 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)\n* 30X109/L ≤ platelet count ≤ 70X109/L\n* C13-urea breath test: positive\n* no previous ITP treatment\n* no previous H. pylori eradication treatment\n* 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\n\nExclusion Criteria:\n\n* Patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, liver disease, definite SLE, drug, MDS, leukemia\n* Uncontrolled hypothyroidism or hyperthyroidism\n* Acute active bleeding or infection\n* Who taking anti-coagulant or aspirin\n* Patients with penicillin allergy\n* Patients with side effects of macrolide.\n* Patients who taking Mizolastine, Terfenadine, Cisapride, Pimozide, Astemizole, Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine), Bepridil, or Atazanavir\n* Patients who have known allergy or severe side effect on study drugs\n* Pregnant or lactating women\n* Clinically relevant hepatic or renal disease (Creatinine clearance ≤ 30mL/min)\n* patients who cannot understand informed consent or express his/her condition'}, 'identificationModule': {'nctId': 'NCT01255332', 'acronym': 'HpyloriITP', 'briefTitle': 'Helicobacter Pylori Immune Thrombocytopenic Purpura', 'organization': {'class': 'NETWORK', 'fullName': 'Cooperative Study Group A for Hematology'}, 'officialTitle': 'Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia', 'orgStudyIdInfo': {'id': 'C-023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'C13-urea breath test: positive', 'description': 'lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Asanbyeongwon-gil, Songpa-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yae-Eun Jang, nurse', 'role': 'CONTACT', 'email': 'redpin75@paran.com', 'phone': '82-2-3010-6378'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyo Jung Kim, professor', 'role': 'CONTACT', 'email': 'hemonc@hallym.or.kr', 'phone': '82-31-380-3859'}], 'overallOfficials': [{'name': 'Jung-Hee Lee, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Hyo Jung Kim, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cooperative Study Group A for Hematology', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'COSAH', 'oldOrganization': 'Cooperative Study Group A for Hematology'}}}}