Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-05-17 @ 9:17 AM
Study NCT ID:
NCT01247194
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2010-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability, as measured by clinical adverse events and laboratory assessments', 'timeFrame': 'up to Study Day 16 (14 days after the last PPI-461 dose)'}, {'measure': 'Antiviral effects of PPI-461, as measured by HCV RNA levels', 'timeFrame': 'Up to Study Day 16 (14 days after the last PPI-461 dose)'}, {'measure': 'PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations', 'timeFrame': 'Up to Study Day 10 (8 days after the last PPI-461 dose)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatitis C', 'NS5A', 'HCV RNA'], 'conditions': ['Chronic Genotype 1 Hepatitis C Virus Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety, tolerability, antiviral effects, and pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria:\n\n* Male or female, between 18 and 65 years of age (female patients must be surgically sterile or 2 years post-menopausal and are required to take a pregnancy test)\n* Body Mass Index (BMI) 18 - 32 kg/m2\n* Chronically infected with hepatitis C genotype-1 virus\n* Serum HCV RNA \\> 5 log10 IU/mL\n* No previous treatment with interferon, peginterferon, ribavirin or any investigational HCV antiviral agents\n* No history of signs or symptoms of decompensated liver disease\n* No known history of cirrhosis\n* No co-infection with HBV, HIV-1, HIV-2\n* No history of any medical condition that may interfere with absorption, distribution or elimination of study drug or with the clinical and laboratory assessments in this study\n* No history of alcohol abuse, or illicit drug use within 2 years prior to Screen, or enrollment in a methadone maintenance program (unless he/she has been enrolled in the methadone program for at least 3 months with good compliance, stable psychosocial circumstances, and no known current risks for recidivism)'}, 'identificationModule': {'nctId': 'NCT01247194', 'briefTitle': 'A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Presidio Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection', 'orgStudyIdInfo': {'id': 'PPI-461-102'}, 'secondaryIdInfos': [{'id': '2010-021510-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort A', 'description': 'PPI-461 50 mg\n\nor placebo', 'interventionNames': ['Drug: PPI-461', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort B', 'description': 'PPI-461 100 mg\n\nor placebo', 'interventionNames': ['Drug: PPI-461', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort C', 'description': 'PPI-461 200 mg\n\nor placebo', 'interventionNames': ['Drug: PPI-461', 'Drug: Placebo']}], 'interventions': [{'name': 'PPI-461', 'type': 'DRUG', 'description': 'capsule, oral, once daily for 3 days', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'capsules, oral, once daily for 3 days', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Local institution', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Local institution', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Local institution', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Herlev', 'country': 'Denmark', 'facility': 'Local institution', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Local institution', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Kolding', 'country': 'Denmark', 'facility': 'Local institution', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Local institution', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Local institution', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Local institution', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Local institution', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nathaniel Brown, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Presidio Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Presidio Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}