Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT00656006
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2005-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C473631', 'term': 'albuferon'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2005-12-20', 'studyFirstSubmitQcDate': '2008-04-09', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.'}, {'measure': 'Primary efficacy end point is sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Chronic', 'Genotype 2 or 3', 'Treatment naive'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.', 'detailedDescription': 'A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a clinical diagnosis of chronic hepatitis C on the basis of detectable serum HCV RNA during the screening period and at least a 6-month history of exposure to risk factors for HCV.\n* Have never received treatment with an interferon alfa product or an interferon alfa combination product.\n* Have HCV genotype 2 or 3.\n* Have compensated liver disease with the following minimum criteria: white blood cell count (WBC) \\>3,000/mm3, absolute neutrophil count (ANC) \\> 1,800/mm3, platelets \\>100,000/mm3, hemoglobin (Hb) \\> 13 g/dL for males and \\> 12 g/dL for females.\n\nExclusion Criteria:\n\n* Evidence of decompensated liver disease.\n* Pregnant or lactating female.\n* History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.\n* A current drug or alcohol addiction.'}, 'identificationModule': {'nctId': 'NCT00656006', 'briefTitle': 'A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3', 'organization': {'class': 'INDUSTRY', 'fullName': 'Human Genome Sciences Inc.'}, 'officialTitle': 'A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3', 'orgStudyIdInfo': {'id': 'HGS1008-C1052 (ALFR-HC-06)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Albuferon', 'type': 'DRUG'}, {'name': 'Ribavirin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 3P1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 2P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Western Ontario', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Human Genome Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Patrick Cronin', 'oldOrganization': 'Human Genome Sciences'}}}}