Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-29 @ 12:17 PM
Study NCT ID:
NCT00402428
Status:
COMPLETED
Last Update Posted:
2013-08-08
First Post:
2006-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients
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': 'D006505', 'term': 'Hepatitis'}], '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': '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': '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2009-09-17', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2006-11-20', 'dispFirstSubmitQcDate': '2009-09-17', 'studyFirstSubmitQcDate': '2006-11-20', 'dispFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virologic response (SVR)', 'timeFrame': 'Week 72'}], 'secondaryOutcomes': [{'measure': 'Rapid virologic response', 'timeFrame': 'Week 4'}, {'measure': 'Early virologic response', 'timeFrame': 'Week 12'}, {'measure': 'Undetectable HCV RNA', 'timeFrame': 'Week 24 and Week 48'}, {'measure': 'Normalization of ALT (a liver enzyme)', 'timeFrame': 'Week 48'}, {'measure': 'Quality of life evaluation', 'timeFrame': 'throughout the entire study'}, {'measure': 'Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing)', 'timeFrame': 'Throughout the entire study'}]}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C', 'Hepatitis C', 'CHC', 'HepC', 'Genotype 1', 'Hepatitis', 'HCV'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '16731032', 'type': 'BACKGROUND', 'citation': 'Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naive patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. doi: 10.1016/j.hepres.2006.04.005. Epub 2006 May 30.'}, {'pmid': '16487617', 'type': 'BACKGROUND', 'citation': 'Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. doi: 10.1016/j.jhep.2005.12.011. Epub 2006 Jan 30.'}, {'type': 'BACKGROUND', 'citation': 'S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006'}, {'type': 'BACKGROUND', 'citation': 'Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006'}, {'pmid': '16518958', 'type': 'BACKGROUND', 'citation': 'Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45.'}, {'pmid': '20600013', 'type': 'DERIVED', 'citation': 'Zeuzem S, Sulkowski MS, Lawitz EJ, Rustgi VK, Rodriguez-Torres M, Bacon BR, Grigorescu M, Tice AD, Lurie Y, Cianciara J, Muir AJ, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-1 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 1. Gastroenterology. 2010 Oct;139(4):1257-66. doi: 10.1053/j.gastro.2010.06.066. Epub 2010 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Diagnosis of chronic hepatitis C.\n* Liver biopsy performed within 2 years of Day 0 or during screening.\n* Infected with hepatitis C virus genotype 1.\n* Interferon alfa treatment naïve (ie, have never been treated with an interferon product).\n* Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.\n* Have compensated liver disease.\n\nKey Exclusion Criteria:\n\n* Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.\n* History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.\n* Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).\n* Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.\n* A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).\n* Active seizure disorder within the last 2 years.\n* Organ transplant other than cornea and hair transplant.\n* Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).\n* Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).\n* Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.\n* Received any experimental agent within 28 days prior to Day 0."}, 'identificationModule': {'nctId': 'NCT00402428', 'briefTitle': 'Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Human Genome Sciences Inc.'}, 'officialTitle': 'Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1', 'orgStudyIdInfo': {'id': 'HGS1008-C1060'}, 'secondaryIdInfos': [{'id': 'ACHIEVE-1', 'type': 'OTHER', 'domain': 'Human Genome Sciences Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day', 'interventionNames': ['Drug: peginterferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day', 'interventionNames': ['Drug: albumin interferon alfa-2b', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day', 'interventionNames': ['Drug: albumin interferon alfa-2b', 'Drug: Ribavirin']}], 'interventions': [{'name': 'albumin interferon alfa-2b', 'type': 'DRUG', 'description': '900 mcg or 1200mcg every two week for 48 weeks', 'armGroupLabels': ['2', '3']}, {'name': 'peginterferon alfa-2a', 'type': 'DRUG', 'description': '180 mcg once a week for 48 weeks', 'armGroupLabels': ['1']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': '1000 mg/day(for subjects \\<75kg) or 1200 mg/day (for subjects\n\n=,\\> 75kg)', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93702', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': 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