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Hepatitis C Virus (HCV)Phase 3NCT04903626

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)

A Phase 3 study testing Glecaprevir/Pibrentasvir (GLE/PIB) in people with Hepatitis C Virus (HCV), run by AbbVie at 70 sites in 8 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

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hepatitis C Virus (HCV)
What is being tested?
Glecaprevir/Pibrentasvir (GLE/PIB)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
70 sitesin 8 countries
Study dates
24 Aug 2021to 17 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

70 sites in 8 countries.

70 sites in 8 countries

United States37 sites

  • Emory Midtown Infectious Disease Clinic /ID# 229927

    Atlanta, Georgia, 30322

  • Mercy Medical Center /ID# 226937

    Baltimore, Maryland, 21202

  • Johns Hopkins Hospital /ID# 230694

    Baltimore, Maryland, 21287

  • AHF Research Center /ID# 254795

    Beverly Hills, California, 90211

  • Arizona Health Research /ID# 233558

    Chandler, Arizona, 85225-2906

  • Velocity Clinical Research Chula Vista /ID# 238352

    Chula Vista, California, 91911-6658

  • The Christ Hospital /ID# 231204

    Cincinnati, Ohio, 45219

  • Duplicate_University Of Cincinnati Medical Center /ID# 226922

    Cincinnati, Ohio, 45267-0585

  • Henry Ford Hospital /ID# 226932

    Detroit, Michigan, 48202

  • Angels Clinical Research Institute /ID# 234090

    Doral, Florida, 33122-1713

  • Coastal Research Institute, LLC /ID# 233233

    Fayetteville, North Carolina, 28304

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

    Fort Lauderdale, Florida, 33308

  • Midway Immunology and Research Center /ID# 229194

    Ft. Pierce, Florida, 34982

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

    Houston, Texas, 77030-2783

  • University of Iowa Hospitals and Clinics /ID# 226934

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center /ID# 232620

    Jackson, Mississippi, 39216-4500

  • Las Vegas Research Center /ID# 255631

    Las Vegas, Nevada, 89106

  • Duplicate_University of Kentucky Chandler Medical Center /ID# 231588

    Lexington, Kentucky, 40536

  • Liver Wellness Center /ID# 244933

    Little Rock, Arkansas, 72204

  • AHF Healthcare Center- Hollywood /ID# 254794

    Los Angeles, California, 90027

  • TLC Clinical Research Inc /ID# 232334

    Los Angeles, California, 90048

  • University of Louisville Hospital /ID# 232139

    Louisville, Kentucky, 40202

  • Wisconsin Medical Center /ID# 230116

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University Medical Center /ID# 241282

    Nashville, Tennessee, 37232-0011

  • Weill Cornell Medical College /ID# 230815

    New York, New York, 10065

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

    Newark, New Jersey, 07103-2842

  • Digestive and Liver Disease Sp /ID# 232633

    Norfolk, Virginia, 23502

  • Midland Research Group, Inc /ID# 231885

    Oakland Park, Florida, 33334-4434

  • Orlando Immunology Center /ID# 229839

    Orlando, Florida, 32803

  • The Institute for Liver Health /ID# 228427

    Peoria, Arizona, 85381

  • Thomas Jefferson University Hospital /ID# 232624

    Philadelphia, Pennsylvania, 19107

  • University Gastroenterology /ID# 233332

    Providence, Rhode Island, 02905

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

    Sacramento, California, 95817

  • Cherokee Nation Outpatient Health Center /ID# 232618

    Tahlequah, Oklahoma, 74464-0545

  • Tampa General Hospital /ID# 228930

    Tampa, Florida, 33606

  • Duplicate_Triple O Research Institute /ID# 229928

    West Palm Beach, Florida, 33407-3100

  • Florida Medical Clinic /ID# 233489

    Zephyrhills, Florida, 33542

Other trials in United States

France7 sites

  • Hopital Beaujon /ID# 246817

    Clichy, Île-de-France Region, 92110

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

    Créteil, Paris, 94010

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

    Lyon, Rhone, 69004

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

    Lyon, Rhone, 69004

  • CHU Montpellier - Hopital Saint Eloi /ID# 229083

    Montpellier, Herault, 34295

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

    Paris, 75012

  • CH de Tourcoing /ID# 233732

    Tourcoing, Nord, 59208

Other trials in France

Germany6 sites

  • zibp-Zentrum fuer Infektiologie /ID# 226765

    Berlin, 10439

  • Universitaetsklinikum Bonn /ID# 226764

    Bonn, North Rhine-Westphalia, 53127

  • Klinikum Dortmund gGmbH /ID# 249689

    Dortmund, North Rhine-Westphalia, 44137

  • Infektiologikum /ID# 226880

    Frankfurt am Main, Hesse, 60596

  • ICH Study Center GmbH & Co KG /ID# 228162

    Hamburg, 20146

  • Klinikum rechts der Isar /ID# 226783

    Munich, 81675

Other trials in Germany

Spain6 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 226698

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 226696

    Barcelona, 08003

  • Hospital Clinic de Barcelona /ID# 226695

    Barcelona, 08036

  • Centro Sanitario Sandoval /ID# 226954

    Madrid, 28010

  • Hospital Universitario Infanta Leonor /ID# 251780

    Madrid, 28031

  • Duplicate_Hospital General Universitario de Valencia /ID# 226709

    Valencia, 46014

Other trials in Spain

Italy5 sites

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

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia /ID# 227081

    Foggia, 71100

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 227079

    Milan, Milano, 20162

  • Azienda Ospedaliera Universitaria Federico II /ID# 227183

    Naples, Napoli, 80131

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078

    Rome, Roma, 00133

Other trials in Italy

Canada4 sites

  • Charlton Medical Centre /ID# 228100

    Hamilton, Ontario, L8N 1Y2

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

    Montreal, Quebec, H4A 3J1

  • Vancouver Infectious Diseases Centre /ID# 227125

    Vancouver, British Columbia, V6Z 2C7

  • CoolAid Medical Clinic /ID# 239978

    Victoria, British Columbia, V8W 1M8

Other trials in Canada

Austria3 sites

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985

    Linz, Upper Austria, 4010

  • Universitaetsklinikum St. Poelten /ID# 227098

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universitaet Wien /ID# 226938

    Vienna, State of Vienna, 1090

Other trials in Austria

Australia2 sites

  • Royal Adelaide Hospital /ID# 227167

    Adelaide, South Australia, 5000

  • The Alfred Hospital /ID# 227169

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

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.

Read more

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.

Being tested
Glecaprevir/Pibrentasvir (GLE/PIB)
Keywords
Acute HCV Infection, HCV Genotype 1-6, Hepatitis C, Glecaprevir, Pibrentasvir, Mavyret
Medical subject headings
Hepatitis C

What participants receive

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

  • Glecaprevir/Pibrentasvir (GLE/PIB)Drug

    Also called ABT-493/ABT-530, Mavyret

    Oral tablets

Study groups in NCT04903626
Study groupRoleWhat they receive
Glecaprevir/PibrentasvirExperimentalParticipants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Receives: Drug: Glecaprevir/Pibrentasvir (GLE/PIB)

What is being measured

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

  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%.

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

Secondary outcomes (4)

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

    SVR12 is defined as the HCV RNA level < 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 92.7%. This efficacy analysis was performed only if success was demonstrated for the primary efficacy analysis, following a fixed-sequence testing procedure.

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

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

    On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log^10 IU/mL above the lowest post-baseline value during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.

    Measured: Up to Week 8

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

    PT relapse is defined as confirmed HCV RNA >= LLOQ between the EOT and 12 weeks after the last dose of study treatment among participants who completed treatment as planned (study treatment duration >= 52 days) with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.

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

  4. Percentage of Participants With PT Reinfection With HCV in the ITT Population

    PT reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period in a participant who had HCV RNA < LLOQ at the final treatment visit, along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.

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

Timeline

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

  1. First posted26 May 2021
  2. Study start24 Aug 2021
  3. Primary completion17 Sep 2024
  4. Study completion17 Sep 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04903626
Sponsor's protocol ID
M20-350
Other IDs
2020-005777-27
Status last verified
Mar 2025
First submitted
24 May 2021
Last updated
6 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Boesecke C, Workowski K, Gordon SC, Cave B, Marcinak J, Miller MG, Semizarov D, Welhaven A, Baumgarten A. Glecaprevir/Pibrentasvir for Acute Hepatitis C Virus Infection in Individuals with a History of Prior Hepatitis C Infection. Infect Dis Ther. 2026 Sep;15(9):2319-2334. doi: 10.1007/s40121-026-01381-w. Epub 2026 Jun 24.

    PubMed 42340583

  • 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. 2026 Apr;84(4):702-712. doi: 10.1016/j.jhep.2025.11.009. Epub 2025 Nov 24.

    PubMed 41297677

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glecaprevir/Pibrentasvir (GLE/PIB) in people with Hepatitis C Virus (HCV), run by AbbVie at 70 sites in 8 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 7 inclusion and 2 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, France, Germany, Spain, Italy and 3 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population (time frame: 12 weeks after last dose of study treatment (Week 20)). 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 NCT04903626, which also lists 2 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 6 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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