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NCT03303599 Clinical Trial

Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Hepatitis C Clinical Trial

Official title:
Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03303599
Other study ID # P17-094
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 13, 2017
Est. completion date January 24, 2020

Study information
Verified date May 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2118
Est. completion date January 24, 2020
Est. primary completion date January 24, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: None.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Medizinische Universität Graz /ID# 169932 Graz Steiermark
Austria Landeskrankenhaus Hall /ID# 169930 Hall in Tirol Tirol
Austria Landeskrankenhaus /ID# 169922 Innsbruck
Austria Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931 Klagenfurt Am Woerthersee Kaernten
Austria KH der Elisabethinen Linz GmbH /ID# 169915 Linz Oberoesterreich
Austria University Hospital St. Polten /ID# 169918 St. Pölten Niederoesterreich
Austria Klinikum Wels - Grieskirchen /ID# 169916 Wels
Austria Wilhelminenspital der Stadt Wien /ID# 169914 Wien
Belgium Algemeen Stedelijk Ziekenhuis /ID# 170876 Aalst Oost-Vlaanderen
Belgium Zna /Id# 170927 Antwerpen
Belgium CHU Saint-Pierre /ID# 170920 Brussels
Belgium Hopital Erasme /ID# 170918 Brussels
Belgium CHU Brugmann /ID# 170956 Bruxelles
Belgium Uza /Id# 170960 Edegem Antwerpen
Belgium Z.O.L - Campus St. Jan /ID# 171058 Genk
Belgium AZ Middelares Gent /ID# 170874 Gent
Belgium UZ Gent /ID# 170922 Gent Oost-Vlaanderen
Belgium Jessa Ziekenhuis /ID# 170958 Hasselt
Belgium AZ Groeninge /ID# 170931 Kortrijk
Belgium Universitair Ziekenhuis Leuven /ID# 170921 Leuven Vlaams-Brabant
Belgium Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930 Liege
Belgium CHC Liege /ID# 170926 Liege
Belgium CHU Ambroise Pare /ID# 171107 Mons
Belgium Centre Hospitalier de Wallonie Picarde /ID# 200822 Tournai Wallonne, Region
Belgium Clinique Edith Cavell /ID# 170932 Uccle
Belgium UCL Saint-Luc /ID# 170964 Woluwe-Saint-Lambert Bruxelles-Capitale
Belgium CHU Dinant Godinne /ID# 170929 Yvoir
France Cabinet medical /ID# 202794 Aix En Provence
France CHU d'Angers /ID# 202500 Angers
France CHU de Besancon - Jean Minjoz /ID# 208502 Besancon Doubs
France Centre Hospitalier de Béziers /ID# 202948 Beziers CEDEX Herault
France Clinique du Tondu /ID# 207508 Bordeaux
France Centre Endo Nord Isere /ID# 204181 Bourgoin Jallieu
France Hopital de la Cavale Blanche /ID# 202640 Brest
France Hopital Antoine Beclere /ID# 202676 Clamart
France CHU Estaing /ID# 202949 Clermont Ferrand
France Hopital Beaujon /ID# 202675 Clichy Ile-de-France
France Centre Hosp Intercommunal de Creteil /ID# 202566 Creteil Val-de-Marne
France Hopital Henri Mondor /ID# 202806 Creteil
France CH Annecy Genevois Site Annecy /ID# 202804 Epagny Metz Tessy Haute-Savoie
France Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957 Grenoble
France CH d'Hyeres /ID# 202515 Hyeres
France Dr. Cuissard, Le Port, FR /ID# 203487 Le Port
France CH Spécialisé Esquirol /ID# 204522 Limoges Haute-Vienne
France CHU Dupuytren /ID# 202514 Limoges CEDEX 1 Franche-Comte
France C.H. de Bretagne Sud /ID# 202362 Lorient
France Hopital de la Croix Rousse /ID# 203071 Lyon
France Hopital Edouard Herriot /ID# 203149 Lyon
France Hopital Europeen /ID# 205073 Marseille
France Hopital Saint Joseph /ID# 202519 Marseille
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 Cabinet Medical, Boyer Darrigr /ID# 202050 Nanterre
France Hopital l'Archet 2 /ID# 205295 Nice
France CHU Nimes /ID# 208200 Nimes Cedex 9
France CH Georges Renon /ID# 202737 Niort CEDEX Deux-Sevres
France CHR Orleans - Hopital de la Source /ID# 202360 Orleans CEDEX 2 Centre-Val De Loire
France Hopital Bichat-Claude Bernard /ID# 202513 Paris
France Hopital Pitie Salpetriere /ID# 202364 Paris
France Hopital Saint Antoine /ID# 202565 Paris Cedex 12
France Centre Hospitalier PERPIGNAN /ID# 205762 Perpignan
France Hopital Haut-Lévêque /ID# 202501 Pessac CEDEX Gironde
France Hopital Robert Debre /ID# 202953 Reims
France Charles Nicolle CHU Rouen /ID# 203518 Rouen CEDEX Seine-Maritime
France Institut Arnault Tzanck /ID# 202363 Saint Laurent Du Var
France Gastrodoc /Id# 206290 St Jean de Vedas
France Hopital Broussais /ID# 202677 St Malo CEDEX Ille-et-Vilaine
France Cabinet Medical, Dr. Constant, /ID# 202361 Toulon
France Clinique Amroise Pare /ID# 205064 Toulouse
France Hopital Joseph Ducuing /ID# 205666 Toulouse
France Hopital Purpan /ID# 202357 TOULOUSE Cedex 9 Haute-Garonne
France Hopital Purpan /ID# 204201 TOULOUSE Cedex 9 Haute-Garonne
France Ctre Hospitalier de Tourcoing /ID# 202358 Tourcoing
France Ctre Hospitalier de Tourcoing /ID# 202805 Tourcoing
France CHU NANCY - Hopital Brabois Adultes /ID# 202570 Vandoeuvre les Nancy CEDEX Meurthe-et-Moselle
France Hopital Paul Brousse /ID# 202623 Villejuif
Greece Gen Univ Hosp Alexandroupolis /ID# 206416 Alexandroupolis
Greece General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414 Athens
Greece General Hospital of Athens Laiko /ID# 206421 Athens Attiki
Greece General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419 Kifissia Attiki
Greece Papageorgiou General Hospital Thessaloniki /ID# 207980 Nea Efkarpia Thessaloniki
Greece Tzaneio general hospital of Piraeus /ID# 208828 Piraeus Attiki
Greece General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420 Pireaus
Greece Bioclinic Thessaloniki /ID# 207981 Thessaloniki
Greece Interbalkan Medical Center /ID# 206417 Thessaloniki
Greece University Gen Hosp AHEPA /ID# 209961 Thessaloniki
Israel HaEmek Medical Center /ID# 169318 Afula
Israel Soroka Medical Center /ID# 169321 Be'er Sheva HaDarom
Israel Assaf Harofeh Medical Center /ID# 169370 Be'er Ya'akov
Israel Maccabi Health Services /ID# 169372 Gush Dan
Israel Hillel Yaffe Medical Center /ID# 169368 Hadera
Israel Bnai Zion Medical Center /ID# 169358 Haifa
Israel Carmel Medical Center /ID# 169309 Haifa
Israel Rambam Medical Center /ID# 169316 Haifa
Israel Gastroenterology Institute, Division of Medicine /ID# 169360 Jerusalem
Israel Shaare Zedek Medical Center /ID# 169329 Jerusalem
Israel Meir Medical Center /ID# 169327 Kfar Saba
Israel Galilee Medical Center /ID# 169325 Nahariya
Israel Rabin Medical Center /ID# 169320 Petakh Tikva
Israel Sheba Medical Center /ID# 169365 Ramat Gan
Israel Tel Aviv Medical Center /ID# 169313 Tel Aviv
Italy Azienda Universitaria Ospedali /ID# 168129 Bari
Italy Ospedale Sant Orsola Malpighi /ID# 168127 Bologna Emilia-Romagna
Italy AOU di Cagliari - Presidio di /ID# 168132 Cagliari
Italy A.O.U Sant'Anna di Ferrara /ID# 168714 Ferrara
Italy AOU Riuniti di Foggia /ID# 168143 Foggia
Italy Ospedale SM Goretti /ID# 169257 Latina
Italy A.O.U. Policlinico G. Martino /ID# 168139 Messina
Italy Azienda Ospedaliera Luigi Sacc /ID# 168136 Milan
Italy Azienda Ospedaliera Luigi Sacc /ID# 168140 Milan
Italy Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137 Milan Lombardia
Italy Ospedale S. Carlo Borromeo /ID# 168144 Milan
Italy ASST Grande Ospedale Metropolitano Niguarda /ID# 168138 Milano Lombardia
Italy ASST Grande Ospedale Metropolitano Niguarda /ID# 168712 Milano Lombardia
Italy Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711 Modena Emilia-Romagna
Italy AOU Federico II /ID# 168131 Naples Campania
Italy Azienda Ospedaliera di Rilievo /ID# 168141 Naples
Italy AO Domenico Cutugno /ID# 168133 Napoli
Italy Universita degli Studi della /ID# 168135 Napoli
Italy Azienda Ospedaliera Maggiore d /ID# 168710 Novara
Italy Azienda Ospedaliera di Padova /ID# 168125 Padua
Italy Azienda Ospedaliera di Padova /ID# 168126 Padua
Italy Policlinico Paolo Giaccone /Id# 168134 Palermo Sicilia
Italy Azienda Ospedaliero - Universi /ID# 168130 Pisa
Italy Fondazione PTV Policlinico Tor Vergata /ID# 168709 Rome Roma
Italy IRCCS Lazzaro Spallanzani /ID# 169234 Rome
Italy Università Cattolica Sacro Cuore /ID# 168781 Rome Roma
Italy IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353 Rozzano Milano
Italy AOU OO. RR. San Giovanni di Di /ID# 168715 Salerno
Italy AOU Citta della Salute Scienza /ID# 168142 Turin Piemonte
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604 Bialystok Podlaskie
Poland Wojewodzki Szpital Obserwacyjn /ID# 209345 Bydgoszcz
Poland Szpital Specjalistyczny W Chorzowie /Id# 209129 Chorzow Slaskie
Poland NZOZ All-Medicus /ID# 208452 Katowice Slaskie
Poland Wojewódzki Szpital Zespolony w Kielcach /ID# 210569 Kielce
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451 Krakow Malopolskie
Poland Wojewodzki Szpit Bieganskiego /ID# 208445 Lodz
Poland Wojewodzki Szpit Bieganskiego /ID# 209608 Lodz
Poland ID Clinic /ID# 208332 Myslowice Slaskie
Poland Szpital Wojewodzki w Opolu /ID# 208444 Opole Opolskie
Poland Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862 Walbrzych Dolnoslaskie
Poland MED-FIX Centrum Medyczne Sp. z /ID# 208453 Warsaw
Poland NZOZ - Lubuska Specjalistyczna Poradnia Chorób Watroby Sp. z o.o. /ID# 208449 Zielona Gora Dolnoslaskie
Poland NZOZ Przychodnia Specjalistycz /ID# 208334 Zychlin Lodzkie
Portugal Hospital Garcia de Orta, E.P.E /ID# 207717 Almada Setubal
Portugal Centro Hospitalar Barreiro Montijo, EPE /ID# 211267 Barreiro Lisboa
Portugal Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910 Lisboa
Portugal Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463 Lisboa
Portugal Centro Hospitalar do Porto EPE /ID# 207733 Porto
Portugal Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195 Vila Nova De Gaia Porto
Switzerland Inselspital, Universitaetsklinik /ID# 201022 Bern
Switzerland Hopitaux Universitaires de Geneve /ID# 203435 Genève Geneve
Switzerland Fondazione Epatocentro Ticino /ID# 201024 Lugano
Switzerland Hopital Neuchatelois /ID# 201026 Neuchatel
Switzerland Kantonsspital St. Gallen /ID# 201025 St. Gallen Sankt Gallen
Switzerland Universitaetsspital Zuerich /ID# 201023 Zurich

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Greece,  Israel,  Italy,  Poland,  Portugal,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12) 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 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir
Secondary Percentage of Participants Taking Concomitant Medications The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir. Up to approximately 28 weeks
Secondary Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed 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). Up to approximately 16 weeks
Secondary Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR) 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). Up to 16 weeks
Secondary Number of Healthcare Resource Utilization (HCRU) 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. Up to approximately 28 weeks
Secondary Percentage of Participants Using Each Treatment Regimen Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks) Up to 16 weeks
Secondary Percentage of Participants with Co-morbidities The percentage of participants with co-morbidities at baseline. Baseline (Day 1)
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