Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT00304551
Status:
COMPLETED
Last Update Posted:
2010-06-03
First Post:
2006-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-01', 'studyFirstSubmitDate': '2006-03-05', 'studyFirstSubmitQcDate': '2006-03-16', 'lastUpdatePostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])', 'timeFrame': 'week 24 from the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Biochemical response (normalization of serum alanine aminotransferase activity)', 'timeFrame': 'at the end of treatment and week 24 form the end of treatment'}, {'measure': 'Virological response (HCV-RNA < 50 IU per milliliter)', 'timeFrame': 'at the end of treatment and week 24 form the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CHC with compensated LC'], 'conditions': ['Liver Cirrhosis', 'Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.\n\nAdditionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.\n\nExclusion Criteria:\n\n* Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)\n* Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)\n* Anemia (less than 12 g hemoglobin per deciliter )\n* Hepatitis B co-infection; decompensated liver disease.\n* Organ transplant\n* Creatinine clearance less than 50 milliliters per minute\n* Poorly controlled psychiatric disease\n* Poorly controlled diabetes\n* Malignant neoplastic disease\n* Severe cardiac or chronic pulmonary disease\n* Immunologically mediated disease\n* Retinopathy'}, 'identificationModule': {'nctId': 'NCT00304551', 'briefTitle': 'A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC', 'orgStudyIdInfo': {'id': 'JV19595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: peginterferon alfa-2a 180μg', 'Drug: ribavirin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: peginterferon alfa-2a 90μg', 'Drug: ribavirin']}, {'type': 'NO_INTERVENTION', 'label': '3'}], 'interventions': [{'name': 'peginterferon alfa-2a 180μg', 'type': 'DRUG', 'description': '180μg（s.c.）/week for 48 weeks', 'armGroupLabels': ['1']}, {'name': 'peginterferon alfa-2a 90μg', 'type': 'DRUG', 'description': '90μg(s.c.)/week for 48 weeks', 'armGroupLabels': ['2']}, {'name': 'ribavirin', 'type': 'DRUG', 'description': '600, 800, or 1,000 mg X 2(p.o.)/day', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan', 'facility': 'Chugoku'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Region'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Kanto Region'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Kinki Region'}, {'city': 'Kyusyu', 'country': 'Japan', 'facility': 'Kyusyu Region'}, {'city': 'Shikoku', 'country': 'Japan', 'facility': 'Shikoku Region'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Tohoku Region', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}, {'city': 'Tōkai', 'country': 'Japan', 'facility': 'Tokai Region', 'geoPoint': {'lat': 35.02269, 'lon': 136.90887}}], 'overallOfficials': [{'name': 'Takehiko Aoshima', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chugai Pharmaceutical', 'oldOrganization': 'Chugai Pharmaceutical'}}}}