The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
NCT ID: NCT02618928
Last Updated: 2019-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
735 participants
OBSERVATIONAL
2015-12-15
2018-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label
* RBV prescribed in line with the current local label
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Hopital Saint Joseph /ID# 144927
Marseille, Bouches-du-Rhone, France
Hopital Saint Joseph /ID# 145560
Marseille, Bouches-du-Rhone, France
Hopital Saint Joseph /ID# 145571
Marseille, Bouches-du-Rhone, France
CHR Orleans - Hopital de la Source /ID# 147250
Orléans, Centre-Val de Loire, France
CHU de Besancon - Jean Minjoz /ID# 145884
Besançon, Doubs, France
CHU Dupuytren /ID# 144920
Limoges, Franche-Comte, France
Hopital Universitaire Purpan /ID# 145869
Toulouse, Haute-Garonne, France
Hopital Universitaire Purpan /ID# 150141
Toulouse, Haute-Garonne, France
Hopital Saint Eloi /ID# 144919
Montpellier, Herault, France
Hopital de la Timone /ID# 145558
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hopital de la Timone /ID# 145574
Marseille, Provence-Alpes-Côte d'Azur Region, France
CHU Amiens Picardie /ID# 145871
Amiens, Somme, France
C.H. du Pays d'Aix /ID# 144922
Aix-en-Provence, , France
Cabinet medical /ID# 147359
Aix-en-Provence, , France
CHU d'Angers /ID# 145880
Angers, , France
Centre Hospitalier Victor Dupo /ID# 147241
Argenteuil, , France
Centre Hospitalier D'Avignon /ID# 151098
Avignon, , France
Centre Hospitalier D'Avignon /ID# 151343
Avignon, , France
Cabinet Medical /ID# 147322
Besançon, , France
Centre Endo Nord Isere /ID# 148694
Bourgoin, , France
Centre Hospitalier Universitai /ID# 147568
Caen, , France
CH de Chambery /ID# 145573
Chambéry, , France
Hopital Antoine Beclere /ID# 149251
Clamart, , France
Hopital Antoine Beclere /ID# 149252
Clamart, , France
Centre Hosp Intercommunal /ID# 145876
Créteil, , France
Hospital Henri Mondor /ID# 144918
Créteil, , France
Clinique du Palais /ID# 145563
Grasse, , France
CHU de Grenoble - Albet Michal /ID# 145881
Grenoble, , France
CH d'Hyeres /ID# 145870
Hyères, , France
Ch Du Mans /Id# 147415
Le Mans, , France
Dr. Cuissard, Le Port, FR /ID# 145565
Le Port, , France
Centre Hospitalier de Libourne /ID# 145564
Libourne, , France
CH Des Deux Vallees Longumeau /ID# 149336
Longjumeau, , France
Hopital de la Croix Rousse /ID# 149776
Lyon, , France
Ctr Consultations La Sauvegard /ID# 147236
Lyon, , France
Hopital de la Timone /ID# 147237
Marseille, , France
Ctre Hosp de Montelimar /ID# 147239
Montélimar, , France
Cabinet Medical, Boyer Darrigr /ID# 145562
Nanterre, , France
CHU de Nice /ID# 144921
Nice, , France
Cabinet Medical, Dr. Verdier, /ID# 145575
Nîmes, , France
Hopital Saint Antoine /ID# 145567
Paris, , France
Hopital Saint Antoine /ID# 148635
Paris, , France
Hopital Saint Antoine /ID# 148693
Paris, , France
Hopital Saint Antoine /ID# 152825
Paris, , France
Cabinet Medical, Giuily /ID# 145882
Paris, , France
Hopital Bichat-Claude Bernard /ID# 149246
Paris, , France
Cabinet Medical /ID# 145559
Paris, , France
Hopital Pitie Salpetriere /ID# 145556
Paris, , France
Hopital Pitie Salpetriere /ID# 145566
Paris, , France
Hopital Pitie Salpetriere /ID# 149337
Paris, , France
Hopital Bichat Claude Bernard /ID# 145886
Paris, , France
Hopital Tenon /ID# 145885
Paris, , France
CH Marechal Joffre /ID# 145875
Perpignan, , France
CHU Jean Bernard /ID# 147414
Poitiers, , France
CHU de Reims /ID# 148477
Reims, , France
Hospital Pontchaillou /ID# 145883
Rennes, , France
Charles Nicolle Hosp chu rouen /ID# 145557
Rouen, , France
Institut Arnault Tzanck /ID# 144925
Saint-Laurent-du-Var, , France
Hopital Begin /ID# 145872
Saint-Mandé, , France
CHU Strasbourg Hautepierre Hos /ID# 147246
Strasbourg, , France
Hopital Foch /ID# 147248
Suresnes, , France
Cabinet Medical, Dr. Constant, /ID# 145561
Toulon, , France
Clinique Amroise Pare /ID# 144924
Toulouse, , France
Hopital Joseph Ducuing /ID# 152832
Toulouse, , France
Ctre Hospitalier de Tourcoing /ID# 145568
Tourcoing, , France
Cabinet Medical, Barbereau /ID# 145874
Tours, , France
Hopital Paul Brousse /ID# 145879
Villejuif, , France
Hopital Paul Brousse /ID# 147244
Villejuif, , France
Hopital Paul Brousse /ID# 147417
Villejuif, , France
Hopital Beaujon /ID# 147923
Clichy, Île-de-France Region, France
Countries
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References
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Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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P15-405
Identifier Type: -
Identifier Source: org_study_id
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