Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-31 @ 1:17 AM
Study NCT ID:
NCT01371604
Status:
COMPLETED
Last Update Posted:
2015-02-06
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Israel', 'Poland', 'Puerto Rico', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-05', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who experience a serious adverse event', 'timeFrame': 'Up to Week 16 and end of treatment (Weeks 24 or 48)'}, {'measure': 'Percentage of participants who experience an adverse event', 'timeFrame': '16 weeks'}, {'measure': 'Percentage of participants who experience a grade 1-4 laboratory abnormality', 'timeFrame': '16 weeks'}, {'measure': 'Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4', 'timeFrame': 'Week 4'}, {'measure': 'Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment', 'timeFrame': 'Weeks 24 or 48'}, {'measure': 'Percentage of participants who achieve sustained virologic response (SVR)', 'timeFrame': '24 weeks after the last dose (Weeks 48 or 72)'}, {'measure': 'Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4', 'timeFrame': 'Week 4'}, {'measure': 'Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment', 'timeFrame': 'Weeks 24 or 48'}, {'measure': 'Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)', 'timeFrame': 'Weeks 48 or 72'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C', 'HCV', 'treatment-naive'], 'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females with documented genotype 1, chronic hepatitis C infection.\n* Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.\n* Has not received prior antiviral treatment for HCV.\n* Written informed consent by participant.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen \\[HBsAg\\] positive) and/or human immunodeficiency virus (HIV).'}, 'identificationModule': {'nctId': 'NCT01371604', 'briefTitle': 'Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection', 'orgStudyIdInfo': {'id': '2355-005'}, 'secondaryIdInfos': [{'id': 'IDX-08C-005', 'type': 'OTHER', 'domain': 'Idenix Protocol Number'}, {'id': '2011-001878-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDX184 50 mg + Peg-IFN/RBV', 'description': 'IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.', 'interventionNames': ['Drug: IDX184', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'IDX184 100 mg + Peg-IFN/RBV', 'description': 'IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.', 'interventionNames': ['Drug: IDX184', 'Biological: Peginterferon alfa-2a (Peg-IFN)', 'Drug: Ribavirin (RBV)']}], 'interventions': [{'name': 'IDX184', 'type': 'DRUG', 'description': 'IDX184 50 mg tablet administered orally', 'armGroupLabels': ['IDX184 100 mg + Peg-IFN/RBV', 'IDX184 50 mg + Peg-IFN/RBV']}, {'name': 'Peginterferon alfa-2a (Peg-IFN)', 'type': 'BIOLOGICAL', 'otherNames': ['Pegasys'], 'description': 'Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly', 'armGroupLabels': ['IDX184 100 mg + Peg-IFN/RBV', 'IDX184 50 mg + Peg-IFN/RBV']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'description': 'Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.', 'armGroupLabels': ['IDX184 100 mg + Peg-IFN/RBV', 'IDX184 50 mg + Peg-IFN/RBV']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to IDX184 50 mg tablet administered orally', 'armGroupLabels': ['IDX184 50 mg + 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'}}}}