Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6
- Conditions
- Hepatitis C
- Registration Number
- NCT03303599
- Lead Sponsor
- AbbVie
- Brief Summary
The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.
This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2118
- Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.
- Participants may be enrolled up to 4 weeks after treatment initiation
- Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial.
None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12) 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir
- Secondary Outcome Measures
Name Time Method Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR) Up to 16 weeks Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease \[MDRD\] equation).
Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed Up to approximately 16 weeks The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken).
Percentage of Participants with Co-morbidities Baseline (Day 1) The percentage of participants with co-morbidities at baseline.
Number of Healthcare Resource Utilization (HCRU) Up to approximately 28 weeks Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call) with an Health Care Provider (HCP) or designee in relation to their HCV infection during the study.
Percentage of Participants Taking Concomitant Medications Up to approximately 28 weeks The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.
Percentage of Participants Using Each Treatment Regimen Up to 16 weeks Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)
Trial Locations
- Locations (156)
Azienda Ospedaliero - Universi /ID# 168130
🇮🇹Pisa, Italy
NZOZ Przychodnia Specjalistycz /ID# 208334
🇵🇱Zychlin, Lodzkie, Poland
Szpital Wojewodzki w Opolu /ID# 208444
🇵🇱Opole, Opolskie, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451
🇵🇱Krakow, Malopolskie, Poland
ID Clinic /ID# 208332
🇵🇱Myslowice, Slaskie, Poland
Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463
🇵🇹Lisboa, Portugal
Zna /Id# 170927
🇧🇪Antwerpen, Belgium
Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931
🇦🇹Klagenfurt Am Woerthersee, Kaernten, Austria
Landeskrankenhaus Hall /ID# 169930
🇦🇹Hall in Tirol, Tirol, Austria
Hopital Edouard Herriot /ID# 203149
🇫🇷Lyon, France
Hopital Bichat-Claude Bernard /ID# 202513
🇫🇷Paris, France
Tel Aviv Medical Center /ID# 169313
🇮🇱Tel Aviv, Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137
🇮🇹Milan, Lombardia, Italy
AOU Federico II /ID# 168131
🇮🇹Naples, Campania, Italy
Ospedale S. Carlo Borromeo /ID# 168144
🇮🇹Milan, Italy
CH Spécialisé Esquirol /ID# 204522
🇫🇷Limoges, Haute-Vienne, France
CHU NANCY - Hopital Brabois Adultes /ID# 202570
🇫🇷Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France
CHU Brugmann /ID# 170956
🇧🇪Bruxelles, Belgium
CH Annecy Genevois Site Annecy /ID# 202804
🇫🇷Epagny Metz Tessy, Haute-Savoie, France
Clinique Amroise Pare /ID# 205064
🇫🇷Toulouse, France
Ctre Hospitalier de Tourcoing /ID# 202358
🇫🇷Tourcoing, France
Soroka Medical Center /ID# 169321
🇮🇱Be'er Sheva, HaDarom, Israel
Shaare Zedek Medical Center /ID# 169329
🇮🇱Jerusalem, Israel
Università Cattolica Sacro Cuore /ID# 168781
🇮🇹Rome, Roma, Italy
Ospedale SM Goretti /ID# 169257
🇮🇹Latina, Italy
AOU di Cagliari - Presidio di /ID# 168132
🇮🇹Cagliari, Italy
Azienda Ospedaliera di Rilievo /ID# 168141
🇮🇹Naples, Italy
Azienda Ospedaliera di Padova /ID# 168125
🇮🇹Padua, Italy
Wojewodzki Szpit Bieganskiego /ID# 209608
🇵🇱Lodz, Poland
Z.O.L - Campus St. Jan /ID# 171058
🇧🇪Genk, Belgium
Jessa Ziekenhuis /ID# 170958
🇧🇪Hasselt, Belgium
CHC Liege /ID# 170926
🇧🇪Liege, Belgium
Clinique Edith Cavell /ID# 170932
🇧🇪Uccle, Belgium
KH der Elisabethinen Linz GmbH /ID# 169915
🇦🇹Linz, Oberoesterreich, Austria
UCL Saint-Luc /ID# 170964
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Centre Hospitalier de Wallonie Picarde /ID# 200822
🇧🇪Tournai, Wallonne, Region, Belgium
AZ Groeninge /ID# 170931
🇧🇪Kortrijk, Belgium
CHU de Besancon - Jean Minjoz /ID# 208502
🇫🇷Besancon, Doubs, France
Landeskrankenhaus /ID# 169922
🇦🇹Innsbruck, Austria
Uza /Id# 170960
🇧🇪Edegem, Antwerpen, Belgium
Algemeen Stedelijk Ziekenhuis /ID# 170876
🇧🇪Aalst, Oost-Vlaanderen, Belgium
Klinikum Wels - Grieskirchen /ID# 169916
🇦🇹Wels, Austria
University Hospital St. Polten /ID# 169918
🇦🇹St. Pölten, Niederoesterreich, Austria
Medizinische Universität Graz /ID# 169932
🇦🇹Graz, Steiermark, Austria
Wilhelminenspital der Stadt Wien /ID# 169914
🇦🇹Wien, Austria
Hopital Erasme /ID# 170918
🇧🇪Brussels, Belgium
CHU Dinant Godinne /ID# 170929
🇧🇪Yvoir, Belgium
CHR Orleans - Hopital de la Source /ID# 202360
🇫🇷Orleans CEDEX 2, Centre-Val De Loire, France
CH Georges Renon /ID# 202737
🇫🇷Niort CEDEX, Deux-Sevres, France
Hopital Purpan /ID# 202357
🇫🇷TOULOUSE Cedex 9, Haute-Garonne, France
Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957
🇫🇷Grenoble, France
CH d'Hyeres /ID# 202515
🇫🇷Hyeres, France
Universitair Ziekenhuis Leuven /ID# 170921
🇧🇪Leuven, Vlaams-Brabant, Belgium
CHU Saint-Pierre /ID# 170920
🇧🇪Brussels, Belgium
UZ Gent /ID# 170922
🇧🇪Gent, Oost-Vlaanderen, Belgium
AZ Middelares Gent /ID# 170874
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930
🇧🇪Liege, Belgium
Hopital Antoine Beclere /ID# 202676
🇫🇷Clamart, France
CHU Estaing /ID# 202949
🇫🇷Clermont Ferrand, France
Centre Hospitalier PERPIGNAN /ID# 205762
🇫🇷Perpignan, France
General Hospital of Athens Laiko /ID# 206421
🇬🇷Athens, Attiki, Greece
Tzaneio general hospital of Piraeus /ID# 208828
🇬🇷Piraeus, Attiki, Greece
Gen Univ Hosp Alexandroupolis /ID# 206416
🇬🇷Alexandroupolis, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414
🇬🇷Athens, Greece
Bioclinic Thessaloniki /ID# 207981
🇬🇷Thessaloniki, Greece
Bnai Zion Medical Center /ID# 169358
🇮🇱Haifa, Israel
Gastroenterology Institute, Division of Medicine /ID# 169360
🇮🇱Jerusalem, Israel
Meir Medical Center /ID# 169327
🇮🇱Kfar Saba, Israel
CHU Ambroise Pare /ID# 171107
🇧🇪Mons, Belgium
CHU Dupuytren /ID# 202514
🇫🇷Limoges CEDEX 1, Franche-Comte, France
Centre Hospitalier de Béziers /ID# 202948
🇫🇷Beziers CEDEX, Herault, France
Centre Hosp Intercommunal de Creteil /ID# 202566
🇫🇷Creteil, Val-de-Marne, France
General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420
🇬🇷Pireaus, Greece
Interbalkan Medical Center /ID# 206417
🇬🇷Thessaloniki, Greece
Hopital Haut-Lévêque /ID# 202501
🇫🇷Pessac CEDEX, Gironde, France
Hopital Purpan /ID# 204201
🇫🇷TOULOUSE Cedex 9, Haute-Garonne, France
Hopital Beaujon /ID# 202675
🇫🇷Clichy, Ile-de-France, France
Hopital Broussais /ID# 202677
🇫🇷St Malo CEDEX, Ille-et-Vilaine, France
Hopital de la Timone /ID# 202792
🇫🇷Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France
Hopital Saint Eloi /ID# 202512
🇫🇷Montpellier CEDEX 5, Herault, France
Charles Nicolle CHU Rouen /ID# 203518
🇫🇷Rouen CEDEX, Seine-Maritime, France
Clinique du Tondu /ID# 207508
🇫🇷Bordeaux, France
Hopital de la Croix Rousse /ID# 203071
🇫🇷Lyon, France
Cabinet medical /ID# 202794
🇫🇷Aix En Provence, France
CHU d'Angers /ID# 202500
🇫🇷Angers, France
Hopital Saint Joseph /ID# 202519
🇫🇷Marseille, France
Hopital Saint Antoine /ID# 202565
🇫🇷Paris Cedex 12, France
Institut Arnault Tzanck /ID# 202363
🇫🇷Saint Laurent Du Var, France
Gastrodoc /Id# 206290
🇫🇷St Jean de Vedas, France
General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419
🇬🇷Kifissia, Attiki, Greece
Papageorgiou General Hospital Thessaloniki /ID# 207980
🇬🇷Nea Efkarpia, Thessaloniki, Greece
AOU Citta della Salute Scienza /ID# 168142
🇮🇹Turin, Piemonte, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711
🇮🇹Modena, Emilia-Romagna, Italy
Centre Endo Nord Isere /ID# 204181
🇫🇷Bourgoin Jallieu, France
Hopital de la Cavale Blanche /ID# 202640
🇫🇷Brest, France
Hopital Henri Mondor /ID# 202806
🇫🇷Creteil, France
Dr. Cuissard, Le Port, FR /ID# 203487
🇫🇷Le Port, France
C.H. de Bretagne Sud /ID# 202362
🇫🇷Lorient, France
CHU Nimes /ID# 208200
🇫🇷Nimes Cedex 9, France
Hopital Europeen /ID# 205073
🇫🇷Marseille, France
Cabinet Medical, Boyer Darrigr /ID# 202050
🇫🇷Nanterre, France
Hopital l'Archet 2 /ID# 205295
🇫🇷Nice, France
Hopital Robert Debre /ID# 202953
🇫🇷Reims, France
Cabinet Medical, Dr. Constant, /ID# 202361
🇫🇷Toulon, France
Hopital Pitie Salpetriere /ID# 202364
🇫🇷Paris, France
Ctre Hospitalier de Tourcoing /ID# 202805
🇫🇷Tourcoing, France
University Gen Hosp AHEPA /ID# 209961
🇬🇷Thessaloniki, Greece
HaEmek Medical Center /ID# 169318
🇮🇱Afula, Israel
Hopital Paul Brousse /ID# 202623
🇫🇷Villejuif, France
Rabin Medical Center /ID# 169320
🇮🇱Petakh Tikva, Israel
ASST Grande Ospedale Metropolitano Niguarda /ID# 168138
🇮🇹Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 168712
🇮🇹Milano, Lombardia, Italy
A.O.U. Policlinico G. Martino /ID# 168139
🇮🇹Messina, Italy
Universita degli Studi della /ID# 168135
🇮🇹Napoli, Italy
Azienda Ospedaliera di Padova /ID# 168126
🇮🇹Padua, Italy
Ospedale Sant Orsola Malpighi /ID# 168127
🇮🇹Bologna, Emilia-Romagna, Italy
Assaf Harofeh Medical Center /ID# 169370
🇮🇱Be'er Ya'akov, Israel
Maccabi Health Services /ID# 169372
🇮🇱Gush Dan, Israel
Rambam Medical Center /ID# 169316
🇮🇱Haifa, Israel
Carmel Medical Center /ID# 169309
🇮🇱Haifa, Israel
Sheba Medical Center /ID# 169365
🇮🇱Ramat Gan, Israel
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353
🇮🇹Rozzano, Milano, Italy
Policlinico Paolo Giaccone /Id# 168134
🇮🇹Palermo, Sicilia, Italy
AOU Riuniti di Foggia /ID# 168143
🇮🇹Foggia, Italy
AO Domenico Cutugno /ID# 168133
🇮🇹Napoli, Italy
Azienda Ospedaliera Maggiore d /ID# 168710
🇮🇹Novara, Italy
AOU OO. RR. San Giovanni di Di /ID# 168715
🇮🇹Salerno, Italy
MED-FIX Centrum Medyczne Sp. z /ID# 208453
🇵🇱Warsaw, Poland
Centro Hospitalar Barreiro Montijo, EPE /ID# 211267
🇵🇹Barreiro, Lisboa, Portugal
Universitaetsspital Zuerich /ID# 201023
🇨🇭Zurich, Switzerland
Hillel Yaffe Medical Center /ID# 169368
🇮🇱Hadera, Israel
Galilee Medical Center /ID# 169325
🇮🇱Nahariya, Israel
Azienda Universitaria Ospedali /ID# 168129
🇮🇹Bari, Italy
Azienda Ospedaliera Luigi Sacc /ID# 168140
🇮🇹Milan, Italy
IRCCS Lazzaro Spallanzani /ID# 169234
🇮🇹Rome, Italy
NZOZ All-Medicus /ID# 208452
🇵🇱Katowice, Slaskie, Poland
Wojewodzki Szpit Bieganskiego /ID# 208445
🇵🇱Lodz, Poland
Hospital Garcia de Orta, E.P.E /ID# 207717
🇵🇹Almada, Setubal, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910
🇵🇹Lisboa, Portugal
Centro Hospitalar do Porto EPE /ID# 207733
🇵🇹Porto, Portugal
Hopitaux Universitaires de Geneve /ID# 203435
🇨🇭Genève, Geneve, Switzerland
Hopital Neuchatelois /ID# 201026
🇨🇭Neuchatel, Switzerland
Fondazione PTV Policlinico Tor Vergata /ID# 168709
🇮🇹Rome, Roma, Italy
A.O.U Sant'Anna di Ferrara /ID# 168714
🇮🇹Ferrara, Italy
Inselspital, Universitaetsklinik /ID# 201022
🇨🇭Bern, Switzerland
Azienda Ospedaliera Luigi Sacc /ID# 168136
🇮🇹Milan, Italy
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862
🇵🇱Walbrzych, Dolnoslaskie, Poland
NZOZ - Lubuska Specjalistyczna Poradnia Chorób Wątroby Sp. z o.o. /ID# 208449
🇵🇱Zielona Gora, Dolnoslaskie, Poland
Kantonsspital St. Gallen /ID# 201025
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604
🇵🇱Bialystok, Podlaskie, Poland
Szpital Specjalistyczny W Chorzowie /Id# 209129
🇵🇱Chorzow, Slaskie, Poland
Wojewodzki Szpital Obserwacyjn /ID# 209345
🇵🇱Bydgoszcz, Poland
Wojewódzki Szpital Zespolony w Kielcach /ID# 210569
🇵🇱Kielce, Poland
Fondazione Epatocentro Ticino /ID# 201024
🇨🇭Lugano, Switzerland
Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195
🇵🇹Vila Nova De Gaia, Porto, Portugal
Hopital Joseph Ducuing /ID# 205666
🇫🇷Toulouse, France