Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-25 @ 4:17 AM
Study NCT ID:
NCT03111966
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2017-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589335', 'term': 'elbasvir'}, {'id': 'C578009', 'term': 'grazoprevir'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'targetDuration': '8 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2017-04-01', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sustained virological response 12 weeks post-treatment (SVR12)', 'timeFrame': '12 weeks after the last dose of study drug', 'description': 'Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12)\n\n• Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.'}], 'secondaryOutcomes': [{'measure': 'virologic failure', 'timeFrame': 'Up to 8 weeks while on treatment', 'description': 'Percentage of patients with virologic failure during treatment\n\n• Measure: Percentage of patients with confirmed \\>=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment or previous unquantifiable HCV up to 12 weeks after last dose of drug'}, {'measure': 'SVR 12 and patients with mild fibrosis', 'timeFrame': 'Up to 12 weeks after last dose of study drug', 'description': 'Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment\n\n• Measure: percentage of patients with a baseline transient elastography \\< 6 kPa'}, {'measure': 'low baseline viral load and SVR12', 'timeFrame': 'Baseline and 12 weeks after the last dose of drug', 'description': 'Percentage of participants with low baseline viral load who achieve sustained\n\n• Measure: HCV RNA levels less than the lower limit of quantification.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '30265418', 'type': 'RESULT', 'citation': 'Hernandez-Conde M, Fernandez I, Perello C, Gallego A, Bonacci M, Pascasio JM, Romero-Gomez M, Llerena S, Fernandez-Rodriguez C, Castro Urda JL, Garcia Buey L, Carmona I, Morillas RM, Garcia ND, Gea F, Carrion JA, Castellote J, Moreno-Planas JM, Piqueras Alcol B, Molina E, Diago M, Montoliu S, de la Vega J, Menendez F, Sanchez Ruano JJ, Garcia-Samaniego J, Rosales-Zabal JM, Anton MD, Badia E, Souto-Rodriguez R, Salmeron FJ, Fernandez-Bermejo M, Figueruela B, Moreno-Palomares JJ, Calleja JL. Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort. J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).', 'detailedDescription': 'This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years to 100 years (adult).\n* Sexes: all\n* Healthy volunteers: no\n* Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03111966', 'briefTitle': 'Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Hepa C'}, 'officialTitle': 'Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spanish cohort with HCV treated with DAA', 'interventionNames': ['Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir']}], 'interventions': [{'name': 'Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir', 'type': 'OTHER', 'description': 'Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir', 'armGroupLabels': ['Spanish cohort with HCV treated with DAA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28020', 'city': 'Madrid', 'country': 'Spain', 'facility': 'HepaC', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepa C', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}