Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-25 @ 7:21 PM
Study NCT ID:
NCT01842451
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2013-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C549273', 'term': 'daclatasvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2015-10-23', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2013-04-24', 'dispFirstSubmitQcDate': '2015-10-23', 'studyFirstSubmitQcDate': '2013-04-24', 'dispFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments', 'timeFrame': 'Up to 64 weeks'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4)', 'timeFrame': 'Up to 20 Weeks'}, {'measure': 'The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)', 'timeFrame': 'Up to 28 weeks'}, {'measure': 'The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)', 'timeFrame': 'Up to 40 weeks'}, {'measure': 'The proportion of subjects who have virologic relapse', 'timeFrame': 'Up to 64 weeks'}, {'measure': 'The proportion of subjects who have virologic breakthrough', 'timeFrame': 'Up to 16 weeks'}, {'measure': 'The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure', 'timeFrame': 'Up to 64 weeks'}, {'measure': 'The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)', 'timeFrame': 'Up to 28 weeks'}, {'measure': 'The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)', 'timeFrame': 'Up to 28 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C', 'CHC', 'HCV', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have genotype 1 CHC and evidence of HCV infection at least 6 months before screening\n* Subjects must be treatment-naïve and have not received prior treatment with any interferon, immunomodulatory agent, or DAA for HCV\n\nExclusion Criteria:\n\n* Evidence of cirrhosis\n* History or other clinical evidence of significant or unstable cardiac disease\n* Any other cause of significant liver disease in addition to hepatitis C\n* Creatinine clearance ≤50 mL/min using the Cockcroft-Gault equation at screening\n* Female subjects who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT01842451', 'briefTitle': 'A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'VX13-135-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VX-135 High Dose with Daclatasvir', 'description': '12 weeks of a high dose of VX-135 in combination with Daclatasvir', 'interventionNames': ['Drug: VX-135', 'Drug: Daclatasvir']}, {'type': 'EXPERIMENTAL', 'label': 'VX-135 Low Dose with Daclatasvir', 'description': '12 weeks of a low dose of VX-135 in combination with Daclatasvir', 'interventionNames': ['Drug: VX-135', 'Drug: Daclatasvir']}], 'interventions': [{'name': 'VX-135', 'type': 'DRUG', 'armGroupLabels': ['VX-135 High Dose with Daclatasvir', 'VX-135 Low Dose with Daclatasvir']}, {'name': 'Daclatasvir', 'type': 'DRUG', 'armGroupLabels': ['VX-135 High Dose with Daclatasvir', 'VX-135 Low Dose with Daclatasvir']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'New Zealand', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}