Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-30 @ 9:09 AM
Study NCT ID:
NCT01447394
Status:
WITHDRAWN
Last Update Posted:
2012-02-03
First Post:
2011-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], '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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600496', 'term': 'peginterferon lambda-1a'}, {'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'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-02', 'studyFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response', 'timeFrame': 'At follow-up Week 24 (SVR24) following 48 weeks of treatment'}, {'measure': 'The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities', 'timeFrame': 'From Day 1 to end of Week 48 on-treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms', 'timeFrame': 'From Day 1 to end of Week 48 on-treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus (HCV)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis C, Genotype 1 or 4\n* HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening\n* Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%\n* Naive to prior anti-HCV therapy\n\nExclusion Criteria:\n\n* Infected with HCV other than Genotype 1 or 4\n* Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening\n* Evidence of liver disease other than HCV\n* Active substance abuse\n* Use of hematologic growth factors within 90 days prior to study randomization\n* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria'}, 'identificationModule': {'nctId': 'NCT01447394', 'briefTitle': 'Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared 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