The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
OPALE
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in France
1 other identifier
observational
735
1 country
70
Brief Summary
This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Typical duration for all trials
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedStudy Start
First participant enrolled
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2018
CompletedResults Posted
Study results publicly available
June 17, 2019
CompletedJune 17, 2019
February 1, 2019
2.3 years
November 24, 2015
March 13, 2019
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
Secondary Outcomes (24)
Percentage of Participants Achieving Virological Response at End of Treatment
End of treatment (week 8, 12, or 24 depending on the treatment regimen)
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment
12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
Percentage of Participants With Relapse
End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
Percentage of Participants With Breakthrough
8, 12, or 24 weeks (depending on the treatment regimen)
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
Week 4
- +19 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Adult patients chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites.
You may qualify if:
- Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4
- 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
You may not qualify if:
- Participant is not participating or intending to participate in a concurrent interventional therapeutic trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (70)
Hopital Saint Joseph /ID# 144927
Marseille, Bouches-du-Rhone, 13285, France
Hopital Saint Joseph /ID# 145560
Marseille, Bouches-du-Rhone, 13285, France
Hopital Saint Joseph /ID# 145571
Marseille, Bouches-du-Rhone, 13285, France
CHR Orleans - Hopital de la Source /ID# 147250
Orléans, Centre-Val de Loire, 45067, France
CHU de Besancon - Jean Minjoz /ID# 145884
Besançon, Doubs, 25000, France
CHU Dupuytren /ID# 144920
Limoges, Franche-Comte, 87042, France
Hopital Universitaire Purpan /ID# 145869
Toulouse, Haute-Garonne, 31059, France
Hopital Universitaire Purpan /ID# 150141
Toulouse, Haute-Garonne, 31059, France
Hopital Saint Eloi /ID# 144919
Montpellier, Herault, 34295, France
Hopital de la Timone /ID# 145558
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
Hopital de la Timone /ID# 145574
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
CHU Amiens Picardie /ID# 145871
Amiens, Somme, 80054, France
C.H. du Pays d'Aix /ID# 144922
Aix-en-Provence, 13090, France
Cabinet medical /ID# 147359
Aix-en-Provence, 13100, France
CHU d'Angers /ID# 145880
Angers, 49933, France
Centre Hospitalier Victor Dupo /ID# 147241
Argenteuil, 95107, France
Centre Hospitalier D'Avignon /ID# 151098
Avignon, 84000, France
Centre Hospitalier D'Avignon /ID# 151343
Avignon, 84000, France
Cabinet Medical /ID# 147322
Besançon, 25000, France
Centre Endo Nord Isere /ID# 148694
Bourgoin, 38300, France
Centre Hospitalier Universitai /ID# 147568
Caen, 14033, France
CH de Chambery /ID# 145573
Chambéry, 7301, France
Hopital Antoine Beclere /ID# 149251
Clamart, 92140, France
Hopital Antoine Beclere /ID# 149252
Clamart, 92140, France
Centre Hosp Intercommunal /ID# 145876
Créteil, 94010, France
Hospital Henri Mondor /ID# 144918
Créteil, 94010, France
Clinique du Palais /ID# 145563
Grasse, 06130, France
CHU de Grenoble - Albet Michal /ID# 145881
Grenoble, 38043, France
CH d'Hyeres /ID# 145870
Hyères, 83407, France
Ch Du Mans /Id# 147415
Le Mans, 72037, France
Dr. Cuissard, Le Port, FR /ID# 145565
Le Port, 97420, France
Centre Hospitalier de Libourne /ID# 145564
Libourne, 33500, France
CH Des Deux Vallees Longumeau /ID# 149336
Longjumeau, 91161, France
Hopital de la Croix Rousse /ID# 149776
Lyon, 69004, France
Ctr Consultations La Sauvegard /ID# 147236
Lyon, 69338, France
Hopital de la Timone /ID# 147237
Marseille, 13385, France
Ctre Hosp de Montelimar /ID# 147239
Montélimar, 26216, France
Cabinet Medical, Boyer Darrigr /ID# 145562
Nanterre, 92000, France
CHU de Nice /ID# 144921
Nice, 06202, France
Cabinet Medical, Dr. Verdier, /ID# 145575
Nîmes, 30900, France
Hopital Saint Antoine /ID# 145567
Paris, 75012, France
Hopital Saint Antoine /ID# 148635
Paris, 75012, France
Hopital Saint Antoine /ID# 148693
Paris, 75012, France
Hopital Saint Antoine /ID# 152825
Paris, 75012, France
Cabinet Medical, Giuily /ID# 145882
Paris, 75016, France
Hopital Bichat-Claude Bernard /ID# 149246
Paris, 75018, France
Cabinet Medical /ID# 145559
Paris, 75020, France
Hopital Pitie Salpetriere /ID# 145556
Paris, 75651, France
Hopital Pitie Salpetriere /ID# 145566
Paris, 75651, France
Hopital Pitie Salpetriere /ID# 149337
Paris, 75651, France
Hopital Bichat Claude Bernard /ID# 145886
Paris, 75877, France
Hopital Tenon /ID# 145885
Paris, 75970, France
CH Marechal Joffre /ID# 145875
Perpignan, 66000, France
CHU Jean Bernard /ID# 147414
Poitiers, 86021, France
CHU de Reims /ID# 148477
Reims, 51092, France
Hospital Pontchaillou /ID# 145883
Rennes, 35033, France
Charles Nicolle Hosp chu rouen /ID# 145557
Rouen, 76031, France
Institut Arnault Tzanck /ID# 144925
Saint-Laurent-du-Var, 06721, France
Hopital Begin /ID# 145872
Saint-Mandé, 94160, France
CHU Strasbourg Hautepierre Hos /ID# 147246
Strasbourg, 67200, France
Hopital Foch /ID# 147248
Suresnes, 92151, France
Cabinet Medical, Dr. Constant, /ID# 145561
Toulon, 83000, France
Clinique Amroise Pare /ID# 144924
Toulouse, 31082, France
Hopital Joseph Ducuing /ID# 152832
Toulouse, 81059, France
Ctre Hospitalier de Tourcoing /ID# 145568
Tourcoing, 59208, France
Cabinet Medical, Barbereau /ID# 145874
Tours, 37100, France
Hopital Paul Brousse /ID# 145879
Villejuif, 94800, France
Hopital Paul Brousse /ID# 147244
Villejuif, 94800, France
Hopital Paul Brousse /ID# 147417
Villejuif, 94800, France
Hopital Beaujon /ID# 147923
Clichy, Île-de-France Region, 92110, France
Related Publications (1)
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.
PMID: 30739368DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2015
First Posted
December 2, 2015
Study Start
December 15, 2015
Primary Completion
March 29, 2018
Study Completion
March 29, 2018
Last Updated
June 17, 2019
Results First Posted
June 17, 2019
Record last verified: 2019-02