Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT03122132
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks
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': 'C586094', 'term': 'ombitasvir'}, {'id': 'C585405', 'term': 'paritaprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C588260', 'term': 'dasabuvir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', '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': 'Percentage of patients with virologic failure during treatment', 'timeFrame': 'Up to 12 weeks after last dose of study drug', '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'}, {'measure': 'Mild fibrosis and sustained virological response 12 weeks post-treatment', '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': 'Percentage of participants with low baseline viral load and SVR12 weeks post-treatment', 'timeFrame': 'Baseline and 12 weeks after the last dose of drug', 'description': 'Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment\n\n• Measure: HCV RNA levels less than the lower limit of quantification.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C Infection', 'Ombitasvir/Paritaprevir/Ritonavir+dasabuvir'], 'conditions': ['Hepatitis C Infection']}, 'referencesModule': {'references': [{'pmid': '30160363', 'type': 'DERIVED', 'citation': 'Puigvehi M, De Cuenca B, Viu A, Diago M, Turnes J, Gea F, Pascasio JM, Lens S, Cabezas J, Badia E, Olveira A, Morillas RM, Torras X, Montoliu S, Cordero P, Castro JL, Salmeron J, Molina E, Sanchez-Ruano JJ, Moreno J, Anton MD, Moreno JM, De la Vega J, Calleja JL, Carrion JA. Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort. Liver Int. 2019 Jan;39(1):90-97. doi: 10.1111/liv.13950. Epub 2018 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).', 'detailedDescription': 'HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HCV who are treated in real practice with Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).\n* Genotype 1b infection\n* Treatment-naïve and non-cirrhotic\n\nExclusion Criteria:\n\n* HCV genotype or subtype other than GT1b.\n* Any current or past clinical evidence of cirrhosis.'}, 'identificationModule': {'nctId': 'NCT03122132', 'acronym': '3D8', 'briefTitle': 'Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks', 'organization': {'class': 'OTHER', 'fullName': 'Hepa C'}, 'officialTitle': 'Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.', 'orgStudyIdInfo': {'id': '0002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spanish cohort with HCV treated with DAA', 'description': 'Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks', 'interventionNames': ['Drug: ombitasvir/paritaprevir/ritonavir 8 weeks', 'Drug: dasabuvir 8 weeks']}], 'interventions': [{'name': 'ombitasvir/paritaprevir/ritonavir 8 weeks', 'type': 'DRUG', 'otherNames': ['viekirax'], 'description': 'Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks', 'armGroupLabels': ['Spanish cohort with HCV treated with DAA']}, {'name': 'dasabuvir 8 weeks', 'type': 'DRUG', 'otherNames': ['exviera'], 'description': 'Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks', 'armGroupLabels': ['Spanish cohort with HCV treated with DAA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Carrion, Jose Antonio, PhD', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepa C', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}