Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-28 @ 4:42 AM
Study NCT ID:
NCT00763568
Status:
COMPLETED
Last Update Posted:
2008-10-01
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006505', 'term': 'Hepatitis'}, {'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': 'C041747', 'term': 'nitazoxanide'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-26', 'studyFirstSubmitDate': '2008-09-26', 'studyFirstSubmitQcDate': '2008-09-26', 'lastUpdatePostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virologic response', 'timeFrame': '24 weeks after the end of treatment'}], 'secondaryOutcomes': [{'measure': 'End of treatment virologic response', 'timeFrame': 'At the end of treatment'}, {'measure': 'Early virologic response', 'timeFrame': 'After 12 weeks of combination therapy'}, {'measure': 'Rapid virologic response', 'timeFrame': 'After 4 weeks of combination therapy'}, {'measure': 'ALT normalization', 'timeFrame': '24 weeks after the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic hepatitis C', 'Viral hepatitis'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis C\n\nExclusion Criteria:\n\n* Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.\n* Unable to take oral medication.\n* Females who are either pregnant, breast-feeding or not using birth control.\n* Males whose female partners are pregnant or plan to become pregnant.\n* Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).\n* Patients with HIV, HAV, HBV or HDV.\n* Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.\n* Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).\n* History of hypersensitivity or intolerance to nitazoxanide or peginterferon.'}, 'identificationModule': {'nctId': 'NCT00763568', 'briefTitle': '4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Romark Laboratories L.C.'}, 'officialTitle': 'Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'RM01-3037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitazoxanide', 'description': 'One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.', 'interventionNames': ['Drug: Nitazoxanide', 'Biological: Peginterferon alfa-2a']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'otherNames': ['Alinia'], 'description': 'One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.', 'armGroupLabels': ['Nitazoxanide']}, {'name': 'Peginterferon alfa-2a', 'type': 'BIOLOGICAL', 'otherNames': ['PEGASYS'], 'description': 'One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.', 'armGroupLabels': ['Nitazoxanide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Digestive Disease Center', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Asem Elfert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Romark Laboratories L.C.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Romark Laboratories, L.C.', 'oldOrganization': 'Romark Laboratories, L.C.'}}}}