A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

NCT03089944 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M16-1352016-004967-38
• Study Type: interventional
• Target: 343
• Locations: 19 countries
• Sites: 113

Brief Summary

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

Conditions

Hepatitis C Virus (HCV)

Keywords

Hepatitis C Virus (HCV); Glecaprevir; Pibrentasvir; Treatment Naïve; Cirrhosis; Compensated Cirrhosis; Genotype (GT) 1-6; Pangenotypic; Chronic Hepatitis C Virus (HCV)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population

  SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. Efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.

  12 weeks after last dose of study drug

• Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population

  SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. Primary efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.

  12 weeks after last dose of study drug

Secondary Outcomes (6)

• Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population

  12 weeks after last dose of study drug

• Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population

  12 weeks after the last dose of study drug

• Percentage of Participants With On-treatment Virologic Failure in the ITT Population

  8 weeks on treatment

• Percentage of Participants With Post-treatment Relapse

  Up to 12 weeks after the last dose of study drug

• Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population

  12 weeks after the last dose of study drug

Study Arms (1)

Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks

EXPERIMENTAL

Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.

Drug: Glecaprevir/Pibrentasvir

Interventions

Glecaprevir/Pibrentasvir DRUG

Tablet

Also known as: ABT-493, ABT-530

Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
• Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
• Treatment-naive to any approved or investigational anti-HCV medication.
• Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.

You may not qualify if:

• Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
• Any current or historical clinical evidence of decompensated cirrhosis.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid \> lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
• HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
• History of suspected or confirmed hepatocellular carcinoma.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (113)

St. Josephs Hosp and Med Ctr /ID# 162762

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic Arizona /ID# 162314

Phoenix, Arizona, 85054, United States

Location

Liver Wellness Center /ID# 162244

Little Rock, Arkansas, 72204, United States

Location

Felizarta /ID# 162295

Bakersfield, California, 93301, United States

Location

VA Long Beach Healthcare System /ID# 162298

Long Beach, California, 90822, United States

Location

Usc /Id# 162248

Los Angeles, California, 90033, United States

Location

Kaiser Permanente - San Diego (Palm Ave) /ID# 162289

San Diego, California, 92154, United States

Location

Stanford University School of Med /ID# 162209

Stanford, California, 94305-2200, United States

Location

Cedars-Sinai Medical Center - West Hollywood /ID# 162313

West Hollywood, California, 90048, United States

Location

University of Miami /ID# 162210

Miami, Florida, 33136, United States

Location

Triple O Research Institute /ID# 162300

West Palm Beach, Florida, 33407-3100, United States

Location

Piedmont Hospital /ID# 162646

Atlanta, Georgia, 30309, United States

Location

Northwestern University Feinberg School of Medicine /ID# 162208

Chicago, Illinois, 60611-2927, United States

Location

Unity Point Health /ID# 162247

Des Moines, Iowa, 50309, United States

Location

The University of Iowa Hospita /ID# 162214

Iowa City, Iowa, 52242, United States

Location

University of Louisville /ID# 162242

Louisville, Kentucky, 40202, United States

Location

Louisiana Research Ctr. LLC /ID# 162567

Shreveport, Louisiana, 71105-6800, United States

Location

Mercy Medical Center /ID# 162291

Baltimore, Maryland, 21202, United States

Location

Mayo Clinic - Rochester /ID# 162251

Rochester, Minnesota, 55905-0001, United States

Location

Southern Therapy and Advanced Research (STAR) LLC /ID# 162241

Jackson, Mississippi, 39216, United States

Location

CHI Health Alegent Creighton /ID# 162286

Omaha, Nebraska, 68124, United States

Location

Univ Nebraska Med Ctr /ID# 162285

Omaha, Nebraska, 68198, United States

Location

Rnjms /Id# 162213

Newark, New Jersey, 07103, United States

Location

Weill Cornell Medical College /ID# 161051

New York, New York, 10021, United States

Location

Icahn School of Med Mt. Sinai /ID# 162294

New York, New York, 10029, United States

Location

Montefiore Medical Center /ID# 162312

The Bronx, New York, 10461, United States

Location

James J. Peters VA Medical Center /ID# 162644

The Bronx, New York, 10468, United States

Location

Duke University Medical Center /ID# 162299

Durham, North Carolina, 27710-3000, United States

Location

Cumberland Research Assoc /ID# 162212

Fayetteville, North Carolina, 28304, United States

Location

Carolinas Center for Liver Dis /ID# 162569

Statesville, North Carolina, 28677-3471, United States

Location

University Hospitals Cleveland /ID# 162243

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic /ID# 162570

Cleveland, Ohio, 44111, United States

Location

Osuchs /Id# 162284

Tulsa, Oklahoma, 74127, United States

Location

Lehigh Valley Health Network /ID# 162603

Allentown, Pennsylvania, 18103, United States

Location

Center for Liver Diseases, Oakland /ID# 162568

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Univ Med Ctr /ID# 162211

Nashville, Tennessee, 37232-0011, United States

Location

Texas Digestive Disease Consul /ID# 162648

Dallas, Texas, 75246-1613, United States

Location

University of Texas Health /ID# 162288

Houston, Texas, 77030-1501, United States

Location

Virginia Commonwealth Univ /ID# 162215

Richmond, Virginia, 23219, United States

Location

Univ of Wisconsin Hosp/Clinics /ID# 162645

Madison, Wisconsin, 53792-0001, United States

Location

Tokuda Hospital Sofia /ID# 163422

Sofia, 1407, Bulgaria

Location

DCC Fokus-5 - LZIP /ID# 163338

Sofia, 1463, Bulgaria

Location

Univ Hosp for Active Treat /ID# 163330

Sofia, 1527, Bulgaria

Location

UMHAT Sv. Ivan Rilski /ID# 163332

Sofia, 1612, Bulgaria

Location

University of Calgary /ID# 161185

Calgary, Alberta, T2N 4Z6, Canada

Location

Percuro Clinical Research, Ltd /ID# 161184

Victoria, British Columbia, V8V 3M9, Canada

Location

Qe Ii Hsc /Id# 161178

Halifax, Nova Scotia, B3H 1V7, Canada

Location

The Ottawa Hospital Research /ID# 161179

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto General Hospital /ID# 161182

Toronto, Ontario, M5G 2C4, Canada

Location

Research Site s.r.o /ID# 163020

Pilsen, 301 00, Czechia

Location

KlinMed s.r.o. /ID# 162893

Prague, 120 00, Czechia

Location

Institut Klinicke a Experimeth /ID# 162900

Prague, 140 21, Czechia

Location

CHR Orleans - Hopital de la Source /ID# 163072

Orléans, Centre-Val de Loire, 45067, France

Location

Hôpital Purpan /ID# 163065

Toulouse, Haute-Garonne, 31059, France

Location

CHU Amiens Picardie /ID# 163071

Amiens, Somme, 80054, France

Location

CHU Estaing /ID# 163058

Clermont-Ferrand, 63100, France

Location

Hospital Henri Mondor /ID# 163061

Créteil, 94010, France

Location

Hopital de la Croix Rousse /ID# 163073

Lyon, 69004, France

Location

General Hospital of Athens Laiko /ID# 162786

Athens, Attica, 115 27, Greece

Location

General and Oncology Hospital /ID# 162784

Kifissia, 14564, Greece

Location

Reg Gen Univ Hosp Larissa /ID# 162783

Larissa, 41110, Greece

Location

Bioclinic Thessaloniki /ID# 162785

Thessaloniki, 54622, Greece

Location

Budai Hepatologiai Centrum /ID# 166511

Budapest, 1111, Hungary

Location

Szent Janos Korhaz /ID# 166542

Budapest, 1125, Hungary

Location

St. James's Hospital /ID# 162619

Dublin, Dublin, D08 E9P6, Ireland

Location

Beaumont Hospital /ID# 162618

Dublin, D09 XR63, Ireland

Location

St Vincent's Hospital /ID# 162617

Dublin, Ireland

Location

Tel Aviv Sourasky Medical Ctr /ID# 162185

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus /ID# 162023

Haifa, 3109601, Israel

Location

The Lady Davis Carmel MC /ID# 162017

Haifa, 3436212, Israel

Location

Sheba Medical Center /ID# 162028

Ramat Gan, 5262100, Israel

Location

Universita della Campania Luigi Vanvitelli /ID# 162337

Napoli, Campania, 80131, Italy

Location

A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335

Bologna, Emilia-Romagna, 40138, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda /ID# 162340

Milan, Lombardy, 20162, Italy

Location

Istituto Clinico Humanitas /ID# 162336

Rozzano, Milano, 20089, Italy

Location

Polo Universitario Luigi Sacco /ID# 162339

Milan, 20157, Italy

Location

Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760

Wroclaw, Lower Silesian Voivodeship, 50-349, Poland

Location

HepID - Diagnostyka I Terapia /ID# 162761

Lublin, Lublin Voivodeship, 20-884, Poland

Location

Uniwersytecki Szpital Kliniczn /ID# 162757

Bialystok, 15-276, Poland

Location

ID Clinic /ID# 162759

Mysłowice, 41-406, Poland

Location

Centro Hosp de Lisboa Central /ID# 163770

Lisbon, Lisbon District, 1169-050, Portugal

Location

Centro Hospitalar Lisboa Norte, EPE /ID# 163785

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar do Porto EPE /ID# 163765

Porto, 4099-001, Portugal

Location

Centro Hospitalar de Sao Joao /ID# 163766

Porto, 4200-319, Portugal

Location

GHGCPR Research Institute /ID# 162608

Ponce, 00716, Puerto Rico

Location

Instituto de Investigacion Cientifica del Sur /ID# 162566

Ponce, 00730, Puerto Rico

Location

Klinical Investigations Group /ID# 162565

San Juan, 00909, Puerto Rico

Location

Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484

Sector 2, București, 021105, Romania

Location

Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449

Sector 2, București, 021105, Romania

Location

Institutul Clinic Fundeni /ID# 163479

Sector 2, București, 022328, Romania

Location

Institutul Clinic Fundeni /ID# 163500

Sector 2, București, 022328, Romania

Location

Institutul Nat. de Boli Infectioase /ID# 163488

Bucharest, 010825, Romania

Location

LLC Medical Company Hepatolog /ID# 161998

Samara, Samara Oblast, 443063, Russia

Location

CBSI Central scientific and research institute of epidemiology /ID# 161996

Moscow, 105275, Russia

Location

Central Clinical Hospital of R /ID# 163434

Moscow, 117593, Russia

Location

Stavropol State Medical Univ /ID# 161999

Stavropol, 355017, Russia

Location

RSAHI Consulting and Diagnostic Centre /ID# 161995

Tyumen, 625026, Russia

Location

Hospital Parc de Salut del Mar /ID# 162198

Barcelona, 08003, Spain

Location

Hospital Univ Vall d'Hebron /ID# 162199

Barcelona, 08035, Spain

Location

Hospital Universitario Reina S /ID# 162200

Córdoba, 14004, Spain

Location

Hospital Donostia /ID# 162197

Donostia / San Sebastian, 20080, Spain

Location

Hospital Univ Central Asturias /ID# 162195

Oviedo, 33011, Spain

Location

China Medical University Hosp /ID# 162950

Taichung, Taichung, 40447, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949

Kaohsiung City, 80708, Taiwan

Location

Taipei Veterans General Hosp /ID# 162776

Taipei, 11217, Taiwan

Location

Basildon University Hospital /ID# 162616

Basildon, Essex, SS16 5NL, United Kingdom

Location

The Royal Free Hospital /ID# 162614

London, London, City of, NW3 2QG, United Kingdom

Location

North Manchester General /ID# 163945

Crumpsall, M8 5RB, United Kingdom

Location

Western General Hospital /ID# 162612

Edinburgh, EH4 2XU, United Kingdom

Location

Queens Medical Centre /ID# 162615

Nottinghamshire, NG7 2UH, United Kingdom

Location

National Hospital of Tropical Diseases /ID# 167974

Hanoi, 100000, Vietnam

Location

Hoa Hao Medic Co. Ltd. /ID# 168178

Ho Chi Minh City, 700000, Vietnam

Location

Tropical Diseases Hospital /ID# 168211

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (1)

• Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horvath G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbanek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.

  PMID: 31682879 DERIVED

MeSH Terms

Conditions

Hepatitis C; Fibrosis; Hepatitis C, Chronic

Interventions

glecaprevir and pibrentasvir; glecaprevir; pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Chronic; Chronic Disease; Disease Attributes

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 24, 2017
• Study Start: April 28, 2017
• Primary Completion: July 31, 2019
• Study Completion: November 8, 2019
• Last Updated: July 13, 2020
• Results First Posted: July 13, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

IE (3); IL (4); RO (5); GB (5); PL (4); PT (4); PR (3); BU (4); HU (2); CA (5); US (40); GR (4); ES (5); RU (5); CZ (3); FR (6); IT (5); VN (3); TW (3)