Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-01 @ 6:46 PM
Study NCT ID:
NCT01591668
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2012-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006505', 'term': 'Hepatitis'}], '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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-12', 'studyFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events in single and multiple doses of GS-9620', 'timeFrame': 'Periodically Day 1 to 6 months', 'description': 'Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements'}], 'secondaryOutcomes': [{'measure': 'Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods', 'timeFrame': 'Day 1 and Day 8', 'description': 'Single ascending dose (SAD) cohorts: serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.\n\nMultiple ascending dose (MAD) cohorts: serial blood samples will be collected on Day 8 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.'}, {'measure': 'Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])', 'timeFrame': 'Days 1, 2, 3, 5, 8', 'description': 'SAD cohorts: Whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hour Post-dose, Day 2, Day 3, Day 5, Day 8\n\nMAD cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hours Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15'}, {'measure': 'Reduction of hepatitis C (HCV) RNA viral load from baseline', 'timeFrame': 'Screening, Baseline, Day 8 or 15', 'description': 'SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits.\n\nMAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis', 'Hepatitis C', 'Chronic HCV', 'HCV', 'Treatment Naive', 'Gilead', 'GS-9620'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '25105516', 'type': 'DERIVED', 'citation': 'Lawitz E, Gruener D, Marbury T, Hill J, Webster L, Hassman D, Nguyen AH, Pflanz S, Mogalian E, Gaggar A, Massetto B, Subramanian GM, McHutchison JG, Jacobson IM, Freilich B, Rodriguez-Torres M. Safety, pharmacokinetics and pharmacodynamics of the oral toll-like receptor 7 agonist GS-9620 in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2015;20(7):699-708. doi: 10.3851/IMP2845. Epub 2014 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females 18-65 years old\n* Chronic HCV infection for at least 6 months, treatment naive\n* HCV Viral load \\> 100,000 IU/mL at Screening\n* Monoinfection with HCV 1 genotype\n* Hepatitis B surface antigen negative\n* Screening ECG without clinically significant abnormalities\n* BMI 18-33 kg/m\\^2\n* Creatinine clearing \\> 70 mL/min\n* Negative pregnancy test at screening\n\nExclusion Criteria:\n\n* Pregnant or lactating subjects\n* Co-infection with hepatitis B virus (HBV) or HIV\n* History of Gilberts disease\n* Particular abnormal laboratory parameters\n* Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed\n* Evidence of hepatocellular carcinoma\n* On-going alcohol abuse\n* Positive uring drug screen'}, 'identificationModule': {'nctId': 'NCT01591668', 'briefTitle': 'A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': 'GS-US-243-0102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.3mg GS-9620', 'interventionNames': ['Drug: Single Ascending Dose Cohorts GS-9620']}, {'type': 'EXPERIMENTAL', 'label': '1mg GS-9620', 'interventionNames': ['Drug: Single Ascending Dose Cohorts GS-9620']}, {'type': 'EXPERIMENTAL', 'label': '2mg GS-9620', 'interventionNames': ['Drug: Single Ascending Dose Cohorts GS-9620']}, {'type': 'EXPERIMENTAL', 'label': '4mg GS-9620', 'interventionNames': ['Drug: Single Ascending Dose Cohorts GS-9620']}, {'type': 'EXPERIMENTAL', 'label': '0.3mg GS-9620 QW x 2 doses', 'interventionNames': ['Drug: Multiple Ascending Dose Cohorts GS-9620']}, {'type': 'EXPERIMENTAL', 'label': '1mg GS-9620 QW x 2 doses', 'interventionNames': ['Drug: Multiple Ascending Dose Cohorts GS-9620']}, {'type': 'EXPERIMENTAL', 'label': '2mg GS-9620 QW x 2 doses', 'interventionNames': ['Drug: Multiple Ascending Dose Cohorts GS-9620']}, {'type': 'EXPERIMENTAL', 'label': '4mg GS-9620 QW x 2 doses', 'interventionNames': ['Drug: Multiple Ascending Dose Cohorts GS-9620']}], 'interventions': [{'name': 'Single Ascending Dose Cohorts GS-9620', 'type': 'DRUG', 'description': 'This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.', 'armGroupLabels': ['0.3mg GS-9620', '1mg GS-9620', '2mg GS-9620', '4mg GS-9620']}, {'name': 'Multiple Ascending Dose Cohorts GS-9620', 'type': 'DRUG', 'description': 'This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).', 'armGroupLabels': ['0.3mg GS-9620 QW x 2 doses', '1mg GS-9620 QW x 2 doses', '2mg GS-9620 QW x 2 doses', '4mg GS-9620 QW x 2 doses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Gastroenterology and Hepatology', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Comprehensive Clinical Research', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CRI Worldwide, LLC', 'geoPoint': {'lat': 40.02789, 'lon': -74.86905}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'CliniLabs', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CRI Worldwide, LLC', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Alamo Medical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Lifetree Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '00909', 'city': 'Santurce', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Fundacion De Investigacion De Diego', 'geoPoint': {'lat': 18.19523, 'lon': -67.14018}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}