Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT00917358
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2009-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pegylated Interferon Alfa-2a for Dialysis Patients With Acute 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': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virologic response (SVR)', 'timeFrame': '1.0 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Dialysis', 'Interferon'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Interferon-based monotherapy has been considered effective to treat acute hepatitis C in ordinary patients. However, the efficacy of this treatment has not been evaluated in prospective interventional studies for dialysis patients. The aim of the study is the evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute hepatitis C who did not receive intervention as the reference.', 'detailedDescription': 'Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. The high incidence and prevalence in thse patients are attributed to potential nosocomial exposure to hepatitis C virus during dialysis, resulting in high rates of acute hepatitis C virus infection. It is estimated that about 65-80% of the patients who have acute hepatitis C will evolve to chronic infection, leading to chronic hepatitis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). Currently, interferon and pegylated interferon monotherapy remains effective to treat acute hepatitis C in ordinary patients, with the sustained virologic response (SVR) rates ranging from 65-90% after 12-24 weeks of therapy. However, few data regarding the efficacy and safety of interferon-based monotherapy is known till now. Treatment of weekly 135 pegylated interferon alfa-2a has shown superior safety to thrice weekly 3 million unit (MU) standard interferon alfa-2a for dialysis patients with chronic hepatitis C. Under the excellent safety profiles of treating dialysis patients with low dose pegylated interferon alfa-2a, we aimed to evaluate the efficacy of weekly 135 ug pegylated interferon alfa-2a for a total of 24 weeks for dialysis patients with acute hepatitis C, and also evaluate the SVR rate by retrospective chart review for dialysis patients with acute hepatitis C who did not receive interferon-based therapy to evaluate if early intervention for these patients will improve overall disease outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years old\n* Creatinine clearance (Ccr) \\< 10 ml/min/1.73 m2\n* Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive \\< 6 months with defined seroconversion\n* Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml\n\nExclusion Criteria:\n\n* Severe anemia (hemoglobin \\< 10 g/dL) or hemoglobinopathy\n* Neutropenia (neutrophil count, \\<1,500/mm3)\n* Thrombocytopenia (platelet \\<90,000/ mm3)\n* Co-infection with HBV or HIV\n* Chronic alcohol abuse (daily consumption \\> 20 g/day)\n* Autoimmune liver disease\n* Decompensated liver disease (Child classification B or C)\n* Neoplastic disease\n* An organ transplant\n* Immunosuppressive therapy\n* Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus\n* Evidence of drug abuse\n* Unwilling to have contraception\n* Unwilling to sign inform consent'}, 'identificationModule': {'nctId': 'NCT00917358', 'briefTitle': 'Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C', 'orgStudyIdInfo': {'id': '940215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegylated interferon alfa-2a', 'description': 'Pegylated interferon alfa-2a 135 ug/week for 24 weeks', 'interventionNames': ['Drug: Pegylated interferon alfa-2a']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention'}], 'interventions': [{'name': 'Pegylated interferon alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)'], 'description': 'Pegylated interferon alfa-2a 135 ug/week for 24 weeks', 'armGroupLabels': ['Pegylated interferon alfa-2a']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Buddhist Tzu Chi General Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Chiayi Christian Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'city': 'Douliu', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital, Yun-Lin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chen-Hua Liu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Jia-Horng Kao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Cheng-Chao Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memorial Hospital'}, {'name': 'Shih-Jer Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital, Yun-Lin Branch'}, {'name': 'Hung-Bin Tsai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buddhist Tzu Chi General Hospital'}, {'name': 'Peir-Haur Hung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiayi Christian Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}