Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT01058512
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate changes in viral load', 'timeFrame': '16 months'}, {'measure': 'To evaluate changes in serum ALT and AST levels', 'timeFrame': '16 months'}, {'measure': 'To evaluate the durability of any changes in viral load and serum ALT and AST', 'timeFrame': '16 months'}, {'measure': 'To establish the safety profile of NOV-205', 'timeFrame': '16 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatitis C', 'chronic HCV', 'viral HCV', 'genotype 1', 'failed treatment with pegylated interferon plus ribavirin'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A serum HCV RNA level of \\>100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = \\~650 IU/ml) or other equally sensitive quantitative methods.\n* Infection with genotype 1 HCV\n* Documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis C\n* Adequate laboratory parameters\n* Women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)\n* Sexually active male subjects are practicing acceptable methods of contraception during trial participation\n* Have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments\n* The subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections\n\nExclusion Criteria:\n\n* Clinical, laboratory, or histological evidence of liver cirrhosis\n* Evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)\n* Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) (as determined by presence of hepatitis B surface antigen (HBsAg)\n* Have received pegylated interferon and/or ribavirin within the 60 days prior to enrollment\n* Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol\n* Pregnant female or nursing mother"}, 'identificationModule': {'nctId': 'NCT01058512', 'acronym': 'NOV-205', 'briefTitle': 'A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellectar Biosciences, Inc.'}, 'officialTitle': 'A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin', 'orgStudyIdInfo': {'id': 'NOV205-C201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single', 'description': 'single-arm study', 'interventionNames': ['Drug: NOV-205']}], 'interventions': [{'name': 'NOV-205', 'type': 'DRUG', 'description': 'There will be 4 treatment Groups with 10 patients in each group:\n\n* Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days\n* Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days\n* Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days\n* Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days', 'armGroupLabels': ['Single']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Borland-Grooover Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33162', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Venture Research Institute, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Immunology Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '01702', 'city': 'Framingham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MetroWest Medical Center', 'geoPoint': {'lat': 42.27926, 'lon': -71.41617}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMASS Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cumberland Research Associates, LLC', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}], 'overallOfficials': [{'name': 'Raymond Koff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellectar Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}