Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01387958
Status:
TERMINATED
Last Update Posted:
2012-05-08
First Post:
2011-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients
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': 'C000594809', 'term': 'pradigastat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'Terminated early due to futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-06', 'studyFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2011-07-05', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure: Change in hepatitis C viral load as assessed by PCR', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.', 'timeFrame': '28 days'}, {'measure': 'Measure: LCQ908 concentrations in the blood', 'timeFrame': 'over 21 days'}]}, 'conditionsModule': {'keywords': ['Hepatitis C virus', 'Chronically infected', 'treatment naive', 'non responders to prior therapy'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '27788579', 'type': 'DERIVED', 'citation': 'Gane E, Stedman C, Dole K, Chen J, Meyers CD, Wiedmann B, Zhang J, Raman P, Colvin RA. A Diacylglycerol Transferase 1 Inhibitor Is a Potent Hepatitis C Antiviral in Vitro but Not in Patients in a Randomized Clinical Trial. ACS Infect Dis. 2017 Feb 10;3(2):144-151. doi: 10.1021/acsinfecdis.6b00138. Epub 2016 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent.\n* Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).\n* No prior therapy or inadequate response to therapy for hepatitis C.\n* Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.\n\nExclusion Criteria:\n\n* Use of other investigational drugs within at least 30 days of enrollment\n* Women of child-bearing potential.\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT01387958', 'briefTitle': 'A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients', 'orgStudyIdInfo': {'id': 'CLCQ908A2214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCQ908', 'interventionNames': ['Drug: LCQ908']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LCQ908', 'type': 'DRUG', 'armGroupLabels': ['LCQ908']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}