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Hepatitis CNCT03303599

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

An observational study of Hepatitis C, run by AbbVie at 156 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hepatitis C
How many people
2,118 participants
Where
156 sitesin 9 countries
Study dates
13 Nov 2017to 24 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients receiving GLE/PIB who have started the treatment combination recommended in the current local label for their disease characteristics.

Who may be able to join

  • 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.

Who cannot join

  • None.

Trial locations and contacts

156 sites in 9 countries.

156 sites in 9 countries

France49 sites

  • Cabinet medical /ID# 202794

    Aix-en-Provence, 13100

  • CHU d'Angers /ID# 202500

    Angers, 49933

  • CHU de Besancon - Jean Minjoz /ID# 208502

    Besançon, Doubs, 25000

  • Centre Hospitalier de Béziers /ID# 202948

    Béziers, Herault, 34525

  • Clinique du Tondu /ID# 207508

    Bordeaux, 33082

  • Centre Endo Nord Isere /ID# 204181

    Bourgoin, 38300

  • Hopital de la Cavale Blanche /ID# 202640

    Brest, 29609

  • Hopital Antoine Beclere /ID# 202676

    Clamart, 92140

  • CHU Estaing /ID# 202949

    Clermont-Ferrand, 63100

  • Hopital Beaujon /ID# 202675

    Clichy, Île-de-France Region, 92110

  • Centre Hosp Intercommunal de Creteil /ID# 202566

    Créteil, Val-de-Marne, 94000

  • Hopital Henri Mondor /ID# 202806

    Créteil, 94010

  • CH Annecy Genevois Site Annecy /ID# 202804

    Epagny Metz Tessy, Haute-Savoie, 74370

  • Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957

    Grenoble, 38043

  • CH d'Hyeres /ID# 202515

    Hyères, 83407

  • Dr. Cuissard, Le Port, FR /ID# 203487

    Le Port, 97420

  • CHU Dupuytren /ID# 202514

    Limoges, Franche-Comte, 87042

  • CH Spécialisé Esquirol /ID# 204522

    Limoges, Haute-Vienne, 87000

  • C.H. de Bretagne Sud /ID# 202362

    Lorient, 56322

  • Hopital de la Croix Rousse /ID# 203071

    Lyon, 69004

  • Hopital Edouard Herriot /ID# 203149

    Lyon, 69437

  • Hopital de la Timone /ID# 202792

    Marseille, Provence-Alpes-Côte d'Azur Region, 13385

  • Hopital Europeen /ID# 205073

    Marseille, 13003

  • Hopital Saint Joseph /ID# 202519

    Marseille, 13008

  • Hopital Saint Eloi /ID# 202512

    Montpellier, Herault, 34295

  • Cabinet Medical, Boyer Darrigr /ID# 202050

    Nanterre, 92000

  • Hopital l'Archet 2 /ID# 205295

    Nice, 06202

  • CHU Nimes /ID# 208200

    Nîmes, 30029

  • CH Georges Renon /ID# 202737

    Niort, Deux-Sevres, 79028

  • CHR Orleans - Hopital de la Source /ID# 202360

    Orléans, Centre-Val de Loire, 45067

  • Hopital Bichat-Claude Bernard /ID# 202513

    Paris, 75018

  • Hopital Saint Antoine /ID# 202565

    Paris, 75571

  • Hopital Pitie Salpetriere /ID# 202364

    Paris, 75651

  • Centre Hospitalier PERPIGNAN /ID# 205762

    Perpignan, 66000

  • Hopital Haut-Lévêque /ID# 202501

    Pessac, Gironde, 33604

  • Hopital Robert Debre /ID# 202953

    Reims, 51092

  • Charles Nicolle CHU Rouen /ID# 203518

    Rouen, Seine-Maritime, 76031

  • Gastrodoc /Id# 206290

    Saint-Jean-de-Védas, 34430

  • Institut Arnault Tzanck /ID# 202363

    Saint-Laurent-du-Var, 06721

  • Hopital Broussais /ID# 202677

    St-Malo, Ille-et-Vilaine, 35403

  • Cabinet Medical, Dr. Constant, /ID# 202361

    Toulon, 83000

  • Hopital Purpan /ID# 202357

    Toulouse, Haute-Garonne, 31059

  • Hopital Purpan /ID# 204201

    Toulouse, Haute-Garonne, 31059

  • Clinique Amroise Pare /ID# 205064

    Toulouse, 31082

  • Hopital Joseph Ducuing /ID# 205666

    Toulouse, 81059

  • Ctre Hospitalier de Tourcoing /ID# 202358

    Tourcoing, 59208

  • Ctre Hospitalier de Tourcoing /ID# 202805

    Tourcoing, 59208

  • CHU NANCY - Hopital Brabois Adultes /ID# 202570

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

  • Hopital Paul Brousse /ID# 202623

    Villejuif, 94800

Other trials in France

Italy29 sites

  • Azienda Universitaria Ospedali /ID# 168129

    Bari, 70120

  • Ospedale Sant Orsola Malpighi /ID# 168127

    Bologna, Emilia-Romagna, 40138

  • AOU di Cagliari - Presidio di /ID# 168132

    Cagliari, 09042

  • A.O.U Sant'Anna di Ferrara /ID# 168714

    Ferrara, 44124

  • AOU Riuniti di Foggia /ID# 168143

    Foggia, 71121

  • Ospedale SM Goretti /ID# 169257

    Latina, 04100

  • A.O.U. Policlinico G. Martino /ID# 168139

    Messina, 98125

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137

    Milan, Lombardy, 20122

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 168138

    Milan, Lombardy, 20162

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 168712

    Milan, Lombardy, 20162

  • Ospedale S. Carlo Borromeo /ID# 168144

    Milan, 20153

  • Azienda Ospedaliera Luigi Sacc /ID# 168136

    Milan, 20157

  • Azienda Ospedaliera Luigi Sacc /ID# 168140

    Milan, 20157

  • Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711

    Modena, Emilia-Romagna, 41124

  • AOU Federico II /ID# 168131

    Naples, Campania, 80131

  • AO Domenico Cutugno /ID# 168133

    Naples, 80131

  • Azienda Ospedaliera di Rilievo /ID# 168141

    Naples, 80131

  • Universita degli Studi della /ID# 168135

    Naples, 80138

  • Azienda Ospedaliera Maggiore d /ID# 168710

    Novara, 28100

  • Azienda Ospedaliera di Padova /ID# 168125

    Padua, 35128

  • Azienda Ospedaliera di Padova /ID# 168126

    Padua, 35128

  • Policlinico Paolo Giaccone /Id# 168134

    Palermo, Sicily, 90127

  • Azienda Ospedaliero - Universi /ID# 168130

    Pisa, 56125

  • Fondazione PTV Policlinico Tor Vergata /ID# 168709

    Rome, Roma, 00133

  • Università Cattolica Sacro Cuore /ID# 168781

    Rome, Roma, 00168

  • IRCCS Lazzaro Spallanzani /ID# 169234

    Rome, 00149

  • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353

    Rozzano, Milano, 20089

  • AOU OO. RR. San Giovanni di Di /ID# 168715

    Salerno, 84131

  • AOU Citta della Salute Scienza /ID# 168142

    Turin, Piedmont, 10126

Other trials in Italy

Belgium19 sites

  • Algemeen Stedelijk Ziekenhuis /ID# 170876

    Aalst, Oost-Vlaanderen, 9300

  • Zna /Id# 170927

    Antwerp, 2060

  • CHU Saint-Pierre /ID# 170920

    Brussels, 1000

  • CHU Brugmann /ID# 170956

    Brussels, 1020

  • Hopital Erasme /ID# 170918

    Brussels, 1070

  • Uza /Id# 170960

    Edegem, Antwerpen, 2650

  • Z.O.L - Campus St. Jan /ID# 171058

    Genk, 3600

  • UZ Gent /ID# 170922

    Ghent, Oost-Vlaanderen, 9000

  • AZ Middelares Gent /ID# 170874

    Ghent, 9000

  • Jessa Ziekenhuis /ID# 170958

    Hasselt, 3500

  • AZ Groeninge /ID# 170931

    Kortrijk, 8500

  • Universitair Ziekenhuis Leuven /ID# 170921

    Leuven, Vlaams-Brabant, 3000

  • Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930

    Liège, 4000

  • CHC Liege /ID# 170926

    Liège, 4000

  • CHU Ambroise Pare /ID# 171107

    Mons, 7000

  • Centre Hospitalier de Wallonie Picarde /ID# 200822

    Tournai, Wallonne, Region, 7500

  • Clinique Edith Cavell /ID# 170932

    Uccle, 1180

  • UCL Saint-Luc /ID# 170964

    Woluwe-Saint-Lambert, Brussels Capital, 1200

  • CHU Dinant Godinne /ID# 170929

    Yvoir, 5530

Other trials in Belgium

Israel15 sites

  • HaEmek Medical Center /ID# 169318

    Afula, 1834111

  • Assaf Harofeh Medical Center /ID# 169370

    Be’er Ya‘aqov, 70300

  • Soroka Medical Center /ID# 169321

    Beersheba, Southern District, 84101

  • Maccabi Health Services /ID# 169372

    GUSH DAN, 7565016

  • Hillel Yaffe Medical Center /ID# 169368

    Hadera, 38100

  • Rambam Medical Center /ID# 169316

    Haifa, 3109601

  • Bnai Zion Medical Center /ID# 169358

    Haifa, 3339419

  • Carmel Medical Center /ID# 169309

    Haifa, 34362

  • Shaare Zedek Medical Center /ID# 169329

    Jerusalem, 91031

  • Gastroenterology Institute, Division of Medicine /ID# 169360

    Jerusalem, 91120

  • Meir Medical Center /ID# 169327

    Kfar Saba, 4428164

  • Galilee Medical Center /ID# 169325

    Nahariya, 2210001

  • Rabin Medical Center /ID# 169320

    Petah Tikva, 4941492

  • Sheba Medical Center /ID# 169365

    Ramat Gan, 5239424

  • Tel Aviv Medical Center /ID# 169313

    Tel Aviv, 64239

Other trials in Israel

Poland14 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604

    Bialystok, Podlaskie Voivodeship, 15-276

  • Wojewodzki Szpital Obserwacyjn /ID# 209345

    Bydgoszcz, 85-030

  • Szpital Specjalistyczny W Chorzowie /Id# 209129

    Chorzów, Silesian Voivodeship, 41-500

  • NZOZ All-Medicus /ID# 208452

    Katowice, Silesian Voivodeship, 40-659

  • Wojewódzki Szpital Zespolony w Kielcach /ID# 210569

    Kielce, 25-736

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451

    Krakow, Lesser Poland Voivodeship, 31-202

  • Wojewodzki Szpit Bieganskiego /ID# 208445

    Lodz, 91-347

  • Wojewodzki Szpit Bieganskiego /ID# 209608

    Lodz, 91-347

  • ID Clinic /ID# 208332

    Mysłowice, Silesian Voivodeship, 41-406

  • Szpital Wojewodzki w Opolu /ID# 208444

    Opole, Opole Voivodeship, 46-020

  • Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862

    Wałbrzych, Lower Silesian Voivodeship, 58-300

  • MED-FIX Centrum Medyczne Sp. z /ID# 208453

    Warsaw, 53-522

  • NZOZ - Lubuska Specjalistyczna Poradnia Chorób Wątroby Sp. z o.o. /ID# 208449

    Zielona GORA, Lower Silesian Voivodeship, 65-191

  • NZOZ Przychodnia Specjalistycz /ID# 208334

    Żychlin, Łódź Voivodeship, 31-956

Other trials in Poland

Greece10 sites

  • Gen Univ Hosp Alexandroupolis /ID# 206416

    Alexandroupoli, 68100

  • General Hospital of Athens Laiko /ID# 206421

    Athens, Attica, 115 27

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414

    Athens, 10676

  • General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419

    Kifissia, Attica, 14564

  • Papageorgiou General Hospital Thessaloniki /ID# 207980

    Nea Efkarpia, Thessaloniki, 54603

  • Tzaneio general hospital of Piraeus /ID# 208828

    Piraeus, Attica, 18536

  • General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420

    Pireaus, 18454

  • Bioclinic Thessaloniki /ID# 207981

    Thessaloniki, 54622

  • University Gen Hosp AHEPA /ID# 209961

    Thessaloniki, 54636

  • Interbalkan Medical Center /ID# 206417

    Thessaloniki, 57001

Other trials in Greece

Austria8 sites

  • Medizinische Universität Graz /ID# 169932

    Graz, Styria, 8020

  • Landeskrankenhaus Hall /ID# 169930

    Hall in Tirol, Tyrol, 6060

  • Landeskrankenhaus /ID# 169922

    Innsbruck, 6020

  • Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931

    Klagenfurt, Carinthia, 9020

  • KH der Elisabethinen Linz GmbH /ID# 169915

    Linz, Upper Austria, 4010

  • University Hospital St. Polten /ID# 169918

    Sankt Pölten, Lower Austria, 3100

  • Wilhelminenspital der Stadt Wien /ID# 169914

    Vienna, 1160

  • Klinikum Wels - Grieskirchen /ID# 169916

    Wels, 4600

Other trials in Austria

Portugal6 sites

  • Hospital Garcia de Orta, E.P.E /ID# 207717

    Almada, Setúbal District, 2805-267

  • Centro Hospitalar Barreiro Montijo, EPE /ID# 211267

    Barreiro, Lisbon District, 2834-003

  • Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463

    Lisbon, 1069-166

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910

    Lisbon, 1649-035

  • Centro Hospitalar do Porto EPE /ID# 207733

    Porto, 4099-001

  • Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Switzerland6 sites

  • Inselspital, Universitaetsklinik /ID# 201022

    Bern, 3010

  • Hopitaux Universitaires de Geneve /ID# 203435

    Geneva, Canton of Geneva, 1205

  • Fondazione Epatocentro Ticino /ID# 201024

    Lugano, 6900

  • Hopital Neuchatelois /ID# 201026

    Neuchâtel, CH-2000

  • Kantonsspital St. Gallen /ID# 201025

    Sankt Gallen, Canton of St. Gallen, 9007

  • Universitaetsspital Zuerich /ID# 201023

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Conditions
Hepatitis C
Keywords
Chronic Hepatitis C, Sustained Virological Response, Chronic Hepatitis C genotype 1, Chronic Hepatitis C genotype 2, Chronic Hepatitis C genotype 3, Chronic Hepatitis C genotype 4, Chronic Hepatitis C genotype 5, Chronic Hepatitis C genotype 6
Medical subject headings
Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03303599
Study groupRoleWhat they receive
HCV Genotypes 1, 2, 3, 4, 5, or 6 participantsParticipants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir

Secondary outcomes (6)

  1. 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.

    Measured: Up to approximately 28 weeks

  2. 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).

    Measured: Up to approximately 16 weeks

  3. 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).

    Measured: Up to 16 weeks

  4. 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.

    Measured: Up to approximately 28 weeks

  5. Percentage of Participants Using Each Treatment Regimen

    Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)

    Measured: Up to 16 weeks

  6. Percentage of Participants with Co-morbidities

    The percentage of participants with co-morbidities at baseline.

    Measured: Baseline (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2017
  2. Study start13 Nov 2017
  3. Primary completion24 Jan 2020
  4. Study completion24 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03303599
Sponsor's protocol ID
P17-094
Status last verified
May 2021
First submitted
3 Oct 2017
Last updated
19 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Vera J, Gomes A, Povoas D, Seixas D, Maltez F, Pedroto I, Maia L, Mota M, Vieira MJ, Manata MJ, Ferreira P, Lino S, Pereira Guedes T, Barradas V, Marques N. Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal. Acta Med Port. 2024 May 2;37(5):323-333. doi: 10.20344/amp.19178. Epub 2024 Feb 7.

    PubMed 38325411

  • Aghemo A, Horsmans Y, Bourgeois S, Bondin M, Gschwantler M, Hofer H, Semmo N, Negro F, Zhang Z, Marcinak J, Veitsman E, Hazzan R, Mimidis K, Goulis I, Marques N, Flisiak R, Mazur W, Roncero C, Marra F, Pageaux GP, Asselah T, Lampertico P. Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir. Infect Dis Ther. 2021 Dec;10(4):2203-2222. doi: 10.1007/s40121-021-00455-1. Epub 2021 Jun 14.

    PubMed 34125405

  • Mullhaupt B, Semela D, Ruckstuhl L, Magenta L, Clerc O, Torgler R, Negro F, Semmo N. Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland. Swiss Med Wkly. 2021 Jan 19;151:w20399. doi: 10.4414/smw.2021.20399. eCollection 2021 Jan 18.

    PubMed 33516161

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by AbbVie at 156 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in France, Italy, Belgium, Israel, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12) (time frame: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03303599, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.

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