Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT01121705
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2010-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006521', 'term': 'Hepatitis, Chronic'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-09', 'studyFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response (SVR)', 'timeFrame': '6 months after the end of treatment', 'description': 'The primary measure of efficacy will be HCV RNA not detectable in the serum 24 weeks after the end of therapy (SVR). In addition, virological response at the end of treatment and relapse rates will be calculated for each groups. Two analyses will be performed: 1) intention-to-treat analysis; 2) per-protocol analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genotype 3', 'Combination treatment', 'Short treatment'], 'conditions': ['Chronic Hepatitis']}, 'referencesModule': {'references': [{'pmid': '18549461', 'type': 'BACKGROUND', 'citation': 'Andriulli A, Mangia A, Iacobellis A, Ippolito A, Leandro G, Zeuzem S. Meta-analysis: the outcome of anti-viral therapy in HCV genotype 2 and genotype 3 infected patients with chronic hepatitis. Aliment Pharmacol Ther. 2008 Aug 15;28(4):397-404. doi: 10.1111/j.1365-2036.2008.03763.x. Epub 2008 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.', 'detailedDescription': 'Patients are randomized to standard length of treatment or to a variable duration: 12 weeks for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable HCV RNA at week 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Naive HCV patients\n* HCVRNA positive\n* Normal TSH\n* ANA \\<1:160\n\nExclusion Criteria:\n\n* Portal hypertension\n* Renal failure\n* HBsAg or HIV\n* Alcohol consumption \\>30 g/day\n* Active IV drug use\n* Chronic systemic diseases'}, 'identificationModule': {'nctId': 'NCT01121705', 'acronym': 'genotype-3', 'briefTitle': 'Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)', 'organization': {'class': 'OTHER', 'fullName': 'Casa Sollievo della Sofferenza IRCCS'}, 'officialTitle': 'Multicenter Study on Efficacy of New Therapeutic Schedules With Peg-Interferon alpha2b and Ribavirin in Patients With Genotype 3 Chronic HCV( Hepatitis C Virus) Infection', 'orgStudyIdInfo': {'id': '2007-00437470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'A1. standard duration', 'description': 'Patients were randomly assigned in a 1:1 ratio to two treatment arms. In the standard treatment group (A1), patients were treated for 24 weeks irrespective of the HCV RNA status at week 4 with Peg-interferon alfa-2b at a dose of 1.5 mcg per kilogram of body weight weekly in combination with oral ribavirin administered at a dose of 1000 mg/day for patients with a weight \\<75 kg or 1200 mg/day for those with a weight of ≥75 kg. Patients enrolled in Arm A1 will be treated for standard 24 weeks duration of treatment with standard dosages of PegInterferon alpha 2b and weight-based dosages of ribavirin.'}, {'type': 'EXPERIMENTAL', 'label': 'B 1 I or II', 'description': 'In the variable treatment group, patients with a virologic response at week 4 will receive treatment for 12 weeks and those without a virologic response at 4 weeks treatment for 36 weeks. Patients without RVR will be treated for 24 or 36 weeks and labelled (B1I) or (B1II, respectively Intervention: different durations of treatment for patients without RVR', 'interventionNames': ['Drug: Peg Interferon alpha2b + Ribavirin']}], 'interventions': [{'name': 'Peg Interferon alpha2b + Ribavirin', 'type': 'DRUG', 'otherNames': ['variable'], 'description': 'B 1 I or II: Experimental\n\nvariable duration of treatment group according with RVR. In case of RVR present patients will be treated for 12 weeks. Patients without RVR will be treated for 24 (B1I) or 36 (B1II)weeks: different duration of treatment for patients without RVR', 'armGroupLabels': ['B 1 I or II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sassari', 'state': 'Sassari', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'city': 'Canossa', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 44.28183, 'lon': 9.92718}}, {'city': 'Casarano', 'country': 'Italy', 'facility': 'Ospedale Casarano', 'geoPoint': {'lat': 40.01131, 'lon': 18.16237}}, {'city': 'Castellana Grotte', 'country': 'Italy', 'facility': 'IRCCS "De Bellis"', 'geoPoint': {'lat': 40.88643, 'lon': 17.16549}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Ospedale "Garibaldi"', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Ospedale "S.Camillo"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Università Cattolica Sacro Cuore Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Venosa', 'country': 'Italy', 'facility': 'Ospedale Venosa', 'geoPoint': {'lat': 40.96283, 'lon': 15.81285}}], 'overallOfficials': [{'name': 'Alessandra Mangia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS - San Giovanni Rotondo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa Sollievo della Sofferenza IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Angelo Andriulli, MD', 'oldOrganization': 'IRCCS "Casa Sollievo della Sofferenza"'}}}}