Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-28 @ 8:17 PM
Study NCT ID:
NCT00004804
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016898', 'term': 'Interferon-alpha'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1997-02', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-02-24', 'studyFirstSubmitQcDate': '2000-02-24', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-02-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['hepatitis C', 'immunologic disorders and infectious disorders', 'rare disease', 'viral infection'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C.\n\nII. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.', 'detailedDescription': 'PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio.\n\nThe first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued.\n\nThe second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\n* Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative\n* No decompensated cirrhosis\n\n--Prior/Concurrent Therapy--\n\n* No concurrent immunosuppressives At least 1 year since interferon\n\n--Patient Characteristics--\n\n* Hepatic: No other cause of liver disease\n* Other: Not HIV positive'}, 'identificationModule': {'nctId': 'NCT00004804', 'briefTitle': 'Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C', 'organization': {'class': 'NIH', 'fullName': 'Office of Rare Diseases (ORD)'}, 'orgStudyIdInfo': {'id': '199/11964'}, 'secondaryIdInfos': [{'id': 'TUMC-M1260'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'interferon alfa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anna S. F. Lok', 'role': 'STUDY_CHAIR', 'affiliation': 'Tulane University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'Tulane University School of Medicine', 'class': 'OTHER'}]}}}