Study of the Effectiveness & Clinical Practice Use of NCT03303599

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
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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External Links

Related Info

Study 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

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Locations

Sponsors (1)

Countries where clinical trial is conducted

Outcome

External Links