Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT00249860
Status:
COMPLETED
Last Update Posted:
2013-08-06
First Post:
2005-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
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': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-04', 'studyFirstSubmitDate': '2005-11-04', 'studyFirstSubmitQcDate': '2005-11-04', 'lastUpdatePostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects achieving sustained viral response (SVR) at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'Percentage of subjects achieving sustained viral response (SVR) at Week 48', 'timeFrame': 'Week 48'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48', 'timeFrame': 'Baseline, Week 12, 24, and 48'}, {'measure': 'Percentage of subjects with Alanine transaminase (ALT) normalization', 'timeFrame': 'Week 12, 24, and 48'}, {'measure': 'Percentage of subjects with viral clearance', 'timeFrame': 'Week 12 and 24'}, {'measure': 'Percentage of subjects with both SVR and sustained ALT normalization', 'timeFrame': 'Week 48'}, {'measure': 'Number of subjects with improvement in the liver necroinflammation score by at least two points', 'timeFrame': 'Week 48'}, {'measure': 'Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point', 'timeFrame': 'Week 48'}, {'measure': 'Number of subjects with adverse events and serious adverse events', 'timeFrame': 'Baseline up to Week 48'}]}, 'conditionsModule': {'keywords': ['Subjects with chronic hepatitis C who have never previously received interferon therapy.'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '17654600', 'type': 'RESULT', 'citation': 'Chan HL, Ren H, Chow WC, Wee T; Interferon beta-1a Hepatitis C Study Group. Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C. Hepatology. 2007 Aug;46(2):315-23. doi: 10.1002/hep.21683.'}], 'seeAlsoLinks': [{'url': 'http://www.mslifelines.com', 'label': 'Full FDA approved prescribing information can be found here'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy.\n\nThis will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks.\n\nThe study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal\n* Had adequate bone marrow reserve and organ function\n* Are not pregnant and are willing to use contraception, if, of childbearing potential\n* Are willing and able to comply with the protocol and to give written informed consent\n* Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy\n* History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures\n* Any cause for the liver disease other than chronic hepatitis C\n* Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse\n* Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody\n* Previous systemic treatment for Hepatitis C with an interferon or ribavirin\n* Presence of systemic disease that might interfere with subject safety, compliance or evaluation\n* Known allergies to acetaminophen, human serum albumin or mannitol;\n* Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment\n* Bearing organ transplants (except cornea)\n* Other protocol defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00249860', 'briefTitle': 'A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects', 'orgStudyIdInfo': {'id': '23744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interferon-beta-1a', 'interventionNames': ['Drug: Interferon-beta-1a']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ribavarin plus interferon-beta-1a', 'interventionNames': ['Drug: Placebo', 'Drug: Ribavirin plus Interferon-beta-1a']}], 'interventions': [{'name': 'Interferon-beta-1a', 'type': 'DRUG', 'description': 'Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24', 'armGroupLabels': ['Interferon-beta-1a']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24', 'armGroupLabels': ['Ribavarin plus interferon-beta-1a']}, {'name': 'Ribavirin plus Interferon-beta-1a', 'type': 'DRUG', 'description': 'Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24', 'armGroupLabels': ['Ribavarin plus interferon-beta-1a']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Theodor Wee, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMD Serono', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Pte. Ltd., Singapore', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}