Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT01310205
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2011-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV
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': 'C470075', 'term': 'golotimod'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2011-03-04', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCV', 'Genotype 1', 'relapsers', 'non cirrhotic', 'Chronic Hepatitis C'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sciclone.com', 'label': 'Sponsor'}]}, 'descriptionModule': {'briefSummary': 'This is an extension of ongoing study SCI-SCV-HCV-P2-001 in which subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV.', 'detailedDescription': 'In this extension study, subjects will be asked to give permission to share their HCV RNA viral load test results, obtained from local laboratories, at the different time points and will also be asked to give permission to share their SOC dosing information (peg-IFN and RBV). As no SCV-07 treatment, procedures, or assessments will be required during this extension study, no related safety information will be collected.\n\nThe study will last up to 72 weeks after subjects complete treatment on study SCI-SCV-HCV-P2-001 and begin retreatment with peg-IFN and RBV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who satisfy all of the following criteria may be enrolled into the study:\n\nSubjects must be able to understand and sign an ICF approved by the investigator's institutional review board (IRB) for this study; must have completed treatment on study SCI-SCV-HCV-P2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current SOC (peg-IFN and RBV).\n\nExclusion Criteria:\n\n* Subjects who satisfy any of the following criteria will not be enrolled into the study:\n\nSubjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-IFN and RBV for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial."}, 'identificationModule': {'nctId': 'NCT01310205', 'briefTitle': 'Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV', 'organization': {'class': 'INDUSTRY', 'fullName': 'SciClone Pharmaceuticals'}, 'officialTitle': 'An Extension of Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Pegylated Interferon and Ribavirin After Completing Treatment in a Phase 2 Study and Have Relapsed After at Least 44 Weeks Tx With Peg-IFN and RBV.', 'orgStudyIdInfo': {'id': 'SCI-SCV-HCV-P2-001-Extension'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatitis C treatment', 'description': 'This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV', 'interventionNames': ['Drug: SCV-07']}, {'label': 'non cirrhotic subjects', 'description': 'This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV', 'interventionNames': ['Drug: SCV-07']}], 'interventions': [{'name': 'SCV-07', 'type': 'DRUG', 'description': 'This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV', 'armGroupLabels': ['Hepatitis C treatment', 'non cirrhotic subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92803', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'AGMG Clinical Research', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Univ of Louisville Med/Dental Complex', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '20307', 'city': 'Washington', 'state': 'Washington', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center'}], 'overallOfficials': [{'name': 'Katharina Modelska, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SciClone Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SciClone Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}