Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01548820
Status:
COMPLETED
Last Update Posted:
2013-09-10
First Post:
2012-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resistance to Lamivudine in HBV Egyptian Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples +/- tissue biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-08', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resistance to Lamivudine Therapy', 'timeFrame': '1 year', 'description': 'Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B virus', 'Lamivudine', 'Resistance to treatment'], 'conditions': ['Chronic Hepatitis B Virus Treatment']}, 'descriptionModule': {'briefSummary': 'On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients', 'detailedDescription': 'Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:\n\n* ALT.\n* HBeAg.\n* HBV-DNA by quantitative PCR.\n* Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \\& Tropical Medicine Research Institute in Egypt in the period from 2007- 2011.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\>18 years old\n* Egyptian nationality\n* Positive serology for HBsAg for more than 6 months\n* Positive HBV viremia (above 2000IU/ml).\n* Lamivudine monotherapy\n\nExclusion Criteria:\n\n* Anti-HBcIgM seropositivity\n* Positive serology for HCV\n* Positive serology for HDV\n* Patients complicated with HCC'}, 'identificationModule': {'nctId': 'NCT01548820', 'briefTitle': 'Resistance to Lamivudine in HBV Egyptian Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy', 'orgStudyIdInfo': {'id': 'HBV resistance'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic HBV Egyptian patients', 'description': 'chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \\& Tropical Medicine Research Institute in Egypt.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Tropical medicine department', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of tropical medicine , Ain Shams university', 'investigatorFullName': 'Iman Fawzy Montasser', 'investigatorAffiliation': 'Ain Shams University'}}}}