Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

NCT04903626 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M20-3502020-005777-27
• Study Type: interventional
• Target: 286
• Locations: 7 countries
• Sites: 68

Brief Summary

HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

Conditions

Hepatitis C Virus (HCV)

Keywords

Acute HCV Infection; HCV Genotype 1-6; Hepatitis C; Glecaprevir; Pibrentasvir; Mavyret

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population

  SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 90.5%.

  12 weeks after last dose of study treatment (Week 20)

Secondary Outcomes (4)

• Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population

  12 weeks after last dose of study treatment (Week 20)

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

  Up to Week 8

• Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population

  Up to 12 weeks after the last dose of study treatment (Week 20)

• Percentage of Participants With PT Reinfection With HCV in the ITT Population

  Up to 12 weeks after the last dose of study treatment (Week 20)

Study Arms (1)

Glecaprevir/Pibrentasvir

EXPERIMENTAL

Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.

Drug: Glecaprevir/Pibrentasvir (GLE/PIB)

Interventions

Glecaprevir/Pibrentasvir (GLE/PIB) DRUG

Oral tablets

Also known as: ABT-493/ABT-530, Mavyret

Glecaprevir/Pibrentasvir

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of acute HCV infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV ribonucleic Acid (RNA) at screening, and at least 1 of the following:
• Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
• Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
• Clinical signs and symptoms compatible with acute hepatitis \[alanine aminotransferase (ALT) \> 5 × upper limit of normal (ULN) and/or jaundice\] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
• Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
• Absence of hepatocellular carcinoma (HCC), for participants with cirrhosis, or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
• Participants documented as having no cirrhosis or as having compensated cirrhosis.

You may not qualify if:

• Participants with prior treatment, including interferon for this HCV infection.
• History of liver decompensation.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (70)

Arizona Health Research /ID# 233558

Chandler, Arizona, 85225-2906, United States

Location

The Institute for Liver Health /ID# 228427

Peoria, Arizona, 85381, United States

Location

Liver Wellness Center /ID# 244933

Little Rock, Arkansas, 72204, United States

Location

AHF Research Center /ID# 254795

Beverly Hills, California, 90211, United States

Location

Velocity Clinical Research Chula Vista /ID# 238352

Chula Vista, California, 91911-6658, United States

Location

AHF Healthcare Center- Hollywood /ID# 254794

Los Angeles, California, 90027, United States

Location

TLC Clinical Research Inc /ID# 232334

Los Angeles, California, 90048, United States

Location

University of California, Davis Comprehensive Cancer Center /ID# 230814

Sacramento, California, 95817, United States

Location

Angels Clinical Research Institute /ID# 234090

Doral, Florida, 33122-1713, United States

Location

AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814

Fort Lauderdale, Florida, 33308, United States

Location

Midway Immunology and Research Center /ID# 229194

Ft. Pierce, Florida, 34982, United States

Location

Midland Research Group, Inc /ID# 231885

Oakland Park, Florida, 33334-4434, United States

Location

Orlando Immunology Center /ID# 229839

Orlando, Florida, 32803, United States

Location

Tampa General Hospital /ID# 228930

Tampa, Florida, 33606, United States

Location

Duplicate_Triple O Research Institute /ID# 229928

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

Location

Florida Medical Clinic /ID# 233489

Zephyrhills, Florida, 33542, United States

Location

Emory Midtown Infectious Disease Clinic /ID# 229927

Atlanta, Georgia, 30322, United States

Location

University of Iowa Hospitals and Clinics /ID# 226934

Iowa City, Iowa, 52242, United States

Location

Duplicate_University of Kentucky Chandler Medical Center /ID# 231588

Lexington, Kentucky, 40536, United States

Location

University of Louisville Hospital /ID# 232139

Louisville, Kentucky, 40202, United States

Location

Mercy Medical Center /ID# 226937

Baltimore, Maryland, 21202, United States

Location

Johns Hopkins Hospital /ID# 230694

Baltimore, Maryland, 21287, United States

Location

Henry Ford Hospital /ID# 226932

Detroit, Michigan, 48202, United States

Location

University of Mississippi Medical Center /ID# 232620

Jackson, Mississippi, 39216-4500, United States

Location

Las Vegas Research Center /ID# 255631

Las Vegas, Nevada, 89106, United States

Location

North Jersey Community Research Initiative (NJCRI) /ID# 245129

Newark, New Jersey, 07103-2842, United States

Location

Weill Cornell Medical College /ID# 230815

New York, New York, 10065, United States

Location

Coastal Research Institute, LLC /ID# 233233

Fayetteville, North Carolina, 28304, United States

Location

The Christ Hospital /ID# 231204

Cincinnati, Ohio, 45219, United States

Location

Duplicate_University Of Cincinnati Medical Center /ID# 226922

Cincinnati, Ohio, 45267-0585, United States

Location

Cherokee Nation Outpatient Health Center /ID# 232618

Tahlequah, Oklahoma, 74464-0545, United States

Location

Thomas Jefferson University Hospital /ID# 232624

Philadelphia, Pennsylvania, 19107, United States

Location

University Gastroenterology /ID# 233332

Providence, Rhode Island, 02905, United States

Location

Vanderbilt University Medical Center /ID# 241282

Nashville, Tennessee, 37232-0011, United States

Location

Liver Associates of Texas, P.A /ID# 229775

Houston, Texas, 77030-2783, United States

Location

Digestive and Liver Disease Sp /ID# 232633

Norfolk, Virginia, 23502, United States

Location

Wisconsin Medical Center /ID# 230116

Milwaukee, Wisconsin, 53226, United States

Location

Royal Adelaide Hospital /ID# 227167

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital /ID# 227169

Melbourne, Victoria, 3004, Australia

Location

Universitaetsklinikum St. Poelten /ID# 227098

Sankt Pölten, Lower Austria, 3100, Austria

Location

Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985

Linz, Upper Austria, 4010, Austria

Location

Medizinische Universitaet Wien /ID# 226938

Vienna, Vienna, 1090, Austria

Location

Vancouver Infectious Diseases Centre /ID# 227125

Vancouver, British Columbia, V6Z 2C7, Canada

Location

CoolAid Medical Clinic /ID# 239978

Victoria, British Columbia, V8W 1M8, Canada

Location

Charlton Medical Centre /ID# 228100

Hamilton, Ontario, L8N 1Y2, Canada

Location

Royal Victoria Hospital / McGill University Health Centre /ID# 227126

Montreal, Quebec, H4A 3J1, Canada

Location

CHU Montpellier - Hopital Saint Eloi /ID# 229083

Montpellier, Herault, 34295, France

Location

CH de Tourcoing /ID# 233732

Tourcoing, Nord, 59208, France

Location

Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259111

Créteil, Paris, 94010, France

Location

HCL - Hopital de la Croix-Rousse /ID# 229077

Lyon, Rhone, 69004, France

Location

HCL - Hopital de la Croix-Rousse /ID# 259102

Lyon, Rhone, 69004, France

Location

AP-HP - Hopital Saint-Antoine /ID# 229070

Paris, 75012, France

Location

Hopital Beaujon /ID# 246817

Clichy, Île-de-France Region, 92110, France

Location

Infektiologikum /ID# 226880

Frankfurt am Main, Hesse, 60596, Germany

Location

Universitaetsklinikum Bonn /ID# 226764

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Klinikum Dortmund gGmbH /ID# 249689

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

zibp-Zentrum fuer Infektiologie /ID# 226765

Berlin, 10439, Germany

Location

ICH Study Center GmbH & Co KG /ID# 228162

Hamburg, 20146, Germany

Location

Klinikum rechts der Isar /ID# 226783

Munich, 81675, Germany

Location

IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 227080

Bologna, Emilia-Romagna, 40138, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda /ID# 227079

Milan, Milano, 20162, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 227183

Naples, Napoli, 80131, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078

Rome, Roma, 00133, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia /ID# 227081

Foggia, 71100, Italy

Location

Hospital Universitario Germans Trias i Pujol /ID# 226698

Badalona, Barcelona, 08916, Spain

Location

Hospital Parc de Salut del Mar /ID# 226696

Barcelona, 08003, Spain

Location

Hospital Clinic de Barcelona /ID# 226695

Barcelona, 08036, Spain

Location

Centro Sanitario Sandoval /ID# 226954

Madrid, 28010, Spain

Location

Hospital Universitario Infanta Leonor /ID# 251780

Madrid, 28031, Spain

Location

Duplicate_Hospital General Universitario de Valencia /ID# 226709

Valencia, 46014, Spain

Location

Related Publications (1)

• Llibre JM, Boesecke C, Moon J, Lank PM, Miller MG, Fredrick LM, Welhaven A, Semizarov D, Marcinak J, Gentile I, Reiberger T, Puoti M. A single-arm phase IIIb study of 8-week glecaprevir/pibrentasvir treatment in adults with acute hepatitis C. J Hepatol. 2025 Nov 24:S0168-8278(25)02625-X. doi: 10.1016/j.jhep.2025.11.009. Online ahead of print.

  PMID: 41297677 DERIVED

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Hepatitis C

Interventions

glecaprevir; pibrentasvir; glecaprevir and 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

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
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 26, 2021
• Study Start: August 24, 2021
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IT (5); AU (3); DE (6); US (37); ES (6); CA (4); FR (7)