Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT01750216
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1', 'timeFrame': 'approximately 3 years'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 3 years'}, {'measure': 'Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1', 'timeFrame': 'approximately 3 years'}, {'measure': 'Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3)', 'timeFrame': 'approximately 3 years'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys and Copegus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Chronic hepatitis C genotype 1\n* Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin\n* Confirmed serum positive HCV RNA\n* Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment\n\nExclusion Criteria:\n\n* Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus\n* Co-infection with hepatitis B or HIV\n* Post-transplant patients\n* End stage renal disease (creatinine clearance \\< 15 ml/min)\n* Patients treated with immunotherapy\n* Pregnant women and male partners of women who are pregnant\n* Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter'}, 'identificationModule': {'nctId': 'NCT01750216', 'briefTitle': 'An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Observational Study of Peginterferon-alfa-2a (Pegasys) and Ribavirin (Copegus) on Predictive Values of RVR on Sustained Virological Response (SVR) in Different Stage of Liver Fibrosis in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'ML28344'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-030', 'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '41-902', 'city': 'Bytom', 'country': 'Poland', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'zip': '41-500', 'city': 'Chorzów', 'country': 'Poland', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '06-400', 'city': 'Ciechanów', 'country': 'Poland', 'geoPoint': {'lat': 52.88141, 'lon': 20.61996}}, {'zip': '39-200', 'city': 'Dębica', 'country': 'Poland', 'geoPoint': {'lat': 50.05146, 'lon': 21.41141}}, {'zip': '40-752', 'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '75-581', 'city': 'Koszalin', 'country': 'Poland', 'geoPoint': {'lat': 54.19438, 'lon': 16.17222}}, {'zip': '91-357', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '39-300', 'city': 'Mielec', 'country': 'Poland', 'geoPoint': {'lat': 50.28709, 'lon': 21.4239}}, {'zip': '24-100', 'city': 'Puławy', 'country': 'Poland', 'geoPoint': {'lat': 51.41655, 'lon': 21.96939}}, {'zip': '26-600', 'city': 'Radom', 'country': 'Poland', 'geoPoint': {'lat': 51.40253, 'lon': 21.14714}}, {'zip': '04-141', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '58-300', 'city': 'Wałbrzych', 'country': 'Poland', 'geoPoint': {'lat': 50.77141, 'lon': 16.28432}}, {'zip': '37-100', 'city': 'Łańcut', 'country': 'Poland', 'geoPoint': {'lat': 50.06871, 'lon': 22.22912}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}