Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT00043303
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2002-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554125', 'term': 'interferon gamma-1b'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-29', 'studyFirstSubmitDate': '2002-08-07', 'studyFirstSubmitQcDate': '2002-08-08', 'lastUpdatePostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ishak fibrosis score', 'timeFrame': '52 weeks'}]}, 'conditionsModule': {'keywords': ['hepatitis C', 'liver fibrosis', 'liver cirrhosis'], 'conditions': ['Liver Fibrosis', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced liver fibrosis and cirrhosis in patients with chronic hepatitis C infections.\n\nIFN-g 1b is not currently approved for the treatment of liver fibrosis.', 'detailedDescription': 'This study will evaluate the safety and tolerability of IFN-g 1b in patients with advanced liver fibrosis and cirrhosis due to hepatitis C. This study will also evaluate whether IFN-g 1b is effective in reducing the amount of fibrosis in the liver.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Men or women 18 to 75 years\n* Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA\n* History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated\n* Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system.\n* Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted)\n* Must meet minimum blood chemistry requirements\n* Cannot have unstable or uncontrolled thyroid disease\n* Cannot have a variety of other diseases (listed in protocol\n* Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study.'}, 'identificationModule': {'nctId': 'NCT00043303', 'briefTitle': 'Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'InterMune'}, 'officialTitle': 'A Multicenter Study of the Safety and Anti-Fibrotic Efficacy of Interferon-Gamma 1b (Actimmune) in Patients With Severe Lever Fibrosis or Compensated Cirrhosis Due to Hepatitis C.', 'orgStudyIdInfo': {'id': 'GILF-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'interferon gamma-1b', 'type': 'DRUG', 'description': '100 or 200 mcg, SQ, 3x per week'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Steven Porter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'InterMune'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InterMune', 'class': 'INDUSTRY'}}}}