Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-03-10 @ 9:47 PM
Study NCT ID:
NCT01011166
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2009-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C557801', 'term': 'IDX184'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-22', 'studyFirstSubmitDate': '2009-10-02', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15', 'timeFrame': 'Baseline and Day 15'}, {'measure': 'Percentage of participants experiencing adverse events (AEs)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of participants experiencing serious adverse events (SAEs)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of participants experiencing dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of participants experiencing Grade 1-4 laboratory abnormalities', 'timeFrame': 'Up to 28 days'}], 'secondaryOutcomes': [{'measure': 'Change in HCV RNA level from Baseline to Day 28', 'timeFrame': 'Baseline and Day 28'}, {'measure': 'Percentage of participants with undetectable HCV RNA at Day 15', 'timeFrame': 'Day 15'}, {'measure': 'Percentage of participants with undetectable HCV RNA at Day 28', 'timeFrame': 'Day 28'}, {'measure': 'Percentage of participants experiencing virologic breakthrough while on study therapy', 'timeFrame': 'Up to 28 days'}, {'measure': 'Change in alanine aminotransferase (ALT) level from Baseline to Day 15', 'timeFrame': 'Baseline and Day 15'}, {'measure': 'Change in ALT level from Baseline to Day 28', 'timeFrame': 'Baseline and Day 28'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Time to maximum concentration (Tmax)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)', 'timeFrame': 'Up to 28 days'}, {'measure': 'AUC from time zero to infinity (AUC0-~)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Trough concentration (Ctrough)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Observed terminal half-life (Thalf)', 'timeFrame': 'Up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C', 'HepC', 'Hep C'], 'conditions': ['Chronic Hepatitis C Infection']}, 'referencesModule': {'references': [{'pmid': '23439365', 'type': 'RESULT', 'citation': "Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. IDX184 in combination with pegylated interferon-alpha2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2013;18(6):755-64. doi: 10.3851/IMP2552. Epub 2013 Feb 25."}]}, 'descriptionModule': {'briefSummary': 'This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has documented chronic HCV GT1 infection\n* Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy\n\nExclusion Criteria:\n\n* Has received previous antiviral treatment for HCV infection\n* Has cirrhosis or decompensated liver disease\n* Is pregnant or breastfeeding\n* Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen \\[HBsAg\\] positive) and/or human immunodeficiency virus (HIV)\n* Has clinically significant concomitant disease'}, 'identificationModule': {'nctId': 'NCT01011166', 'briefTitle': 'Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects With Genotype 1 Chronic Hepatitis C Infection', 'orgStudyIdInfo': {'id': '2355-004'}, 'secondaryIdInfos': [{'id': 'IDX-08C-004', 'type': 'OTHER', 'domain': 'Idenix Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDX184 50 mg QD + Peg-IFN/RBV', 'description': 'Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.', 'interventionNames': ['Drug: IDX184', 'Drug: Placebo', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'IDX184 100 mg QD + Peg-IFN/RBV', 'description': 'Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.', 'interventionNames': ['Drug: IDX184', 'Drug: Placebo', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'IDX184 100 mg BID + Peg-IFN/RBV', 'description': 'Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.', 'interventionNames': ['Drug: IDX184', 'Drug: Placebo', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'IDX184 150 mg QD + Peg-IFN/RBV', 'description': 'Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.', 'interventionNames': ['Drug: IDX184', 'Drug: Placebo', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'IDX184 200 mg QD + Peg-IFN/RBV', 'description': 'Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.', 'interventionNames': ['Drug: IDX184', 'Drug: Placebo', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'IDX184 200 mg BID + Peg-IFN/RBV', 'description': 'Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.', 'interventionNames': ['Drug: IDX184', 'Drug: Placebo', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)']}], 'interventions': [{'name': 'IDX184', 'type': 'DRUG', 'description': 'IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.', 'armGroupLabels': ['IDX184 100 mg BID + Peg-IFN/RBV', 'IDX184 100 mg QD + Peg-IFN/RBV', 'IDX184 150 mg QD + Peg-IFN/RBV', 'IDX184 200 mg BID + Peg-IFN/RBV', 'IDX184 200 mg QD + Peg-IFN/RBV', 'IDX184 50 mg QD + Peg-IFN/RBV']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo white opaque capsules taken by mouth from Day 1 to Day 14.', 'armGroupLabels': ['IDX184 100 mg BID + Peg-IFN/RBV', 'IDX184 100 mg QD + Peg-IFN/RBV', 'IDX184 150 mg QD + Peg-IFN/RBV', 'IDX184 200 mg BID + Peg-IFN/RBV', 'IDX184 200 mg QD + Peg-IFN/RBV', 'IDX184 50 mg QD + Peg-IFN/RBV']}, {'name': 'Peginterferon alfa-2a (Peg-IFN)', 'type': 'BIOLOGICAL', 'otherNames': ['Pegasys'], 'description': 'Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.', 'armGroupLabels': ['IDX184 100 mg BID + Peg-IFN/RBV', 'IDX184 100 mg QD + Peg-IFN/RBV', 'IDX184 150 mg QD + Peg-IFN/RBV', 'IDX184 200 mg BID + Peg-IFN/RBV', 'IDX184 200 mg QD + Peg-IFN/RBV', 'IDX184 50 mg QD + Peg-IFN/RBV']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'description': 'RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.', 'armGroupLabels': ['IDX184 100 mg BID + Peg-IFN/RBV', 'IDX184 100 mg QD + Peg-IFN/RBV', 'IDX184 150 mg QD + Peg-IFN/RBV', 'IDX184 200 mg BID + Peg-IFN/RBV', 'IDX184 200 mg QD + Peg-IFN/RBV', 'IDX184 50 mg QD + Peg-IFN/RBV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}