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)

April 19, 2024 updated by: AbbVie

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

Hepatitis C Virus (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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital /ID# 227167
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health /ID# 227169
  • Austria
    • Niederoesterreich
      • Sankt Poelten, Niederoesterreich, Austria, 3100
        • Universitaetsklinikum St. Poelten /ID# 227098
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, 4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitaet Wien /ID# 226938
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Vancouver Infectious Diseases Centre /ID# 227125
      • Victoria, British Columbia, Canada, V8W 1M8
        • CoolAid Medical Clinic /ID# 239978
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Charlton Medical Centre /ID# 228100
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital / McGill University Health Centre /ID# 227126
  • France
      • Créteil, France, 94010
        • Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 259111
      • Paris, France, 75012
        • AP-HP - Hopital Saint-Antoine /ID# 229070
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • CHU Montpellier - Hôpital Saint Eloi /ID# 229083
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hopital Beaujon /ID# 246817
    • Nord
      • TOURCOING Cedex, Nord, France, 59208
        • CH de Tourcoing /ID# 233732
    • Rhone
      • Lyon, Rhone, France, 69004
        • HCL - Hopital de la Croix-Rousse /ID# 229077
      • Lyon, Rhone, France, 69004
        • HCL - Hopital de la Croix-Rousse /ID# 259102
  • Germany
      • Berlin, Germany, 10439
        • zibp-Zentrum fuer Infektiologie /ID# 226765
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 226764
      • Dortmund, Germany, 44137
        • Klinikum Dortmund gGmbH /ID# 249689
      • Frankfurt am Main, Germany, 60596
        • Infektiologikum /ID# 226880
      • Hamburg, Germany, 20146
        • ICH Study Center GmbH & Co KG /ID# 228162
      • Munich, Germany, 81675
        • Klinikum rechts der Isar /ID# 226783
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080
      • Foggia, Italy, 71122
        • Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II /ID# 227183
    • Milano
      • Milan, Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda /ID# 227079
    • Roma
      • Rome, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Parc de Salut del Mar /ID# 226696
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 226695
      • Madrid, Spain, 28010
        • Centro Sanitario Sandoval /ID# 226954
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor /ID# 251780
      • Valencia, Spain, 46014
        • Duplicate_Hospital General Universitario de Valencia /ID# 226709
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol /ID# 226698
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225-2906
        • Arizona Health Research /ID# 233558
      • Peoria, Arizona, United States, 85381
        • The Institute for Liver Health /ID# 228427
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Liver Wellness Center /ID# 244933
    • California
      • Beverly Hills, California, United States, 90211
        • AHF Research Center /ID# 254795
      • Chula Vista, California, United States, 91911-6658
        • Velocity Clinical Research Chula Vista /ID# 238352
      • Los Angeles, California, United States, 90027
        • AHF Healthcare Center- Hollywood /ID# 254794
      • Los Angeles, California, United States, 90048
        • TLC Clinical Research Inc /ID# 232334
      • Sacramento, California, United States, 95817
        • University of California, Davis Comprehensive Cancer Center /ID# 230814
    • Florida
      • Doral, Florida, United States, 33122-1713
        • Angels Clinical Research Institute /ID# 234090
      • Fort Lauderdale, Florida, United States, 33308
        • AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology and Research Center /ID# 229194
      • Oakland Park, Florida, United States, 33334-4434
        • Midland Research Group, Inc /ID# 231885
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center /ID# 229839
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital /ID# 228930
      • West Palm Beach, Florida, United States, 33407-3100
        • Triple O Research Institute /ID# 229928
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic /ID# 233489
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Midtown Infectious Disease Clinic /ID# 229927
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics /ID# 226934
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center /ID# 231588
      • Louisville, Kentucky, United States, 40202-1821
        • University of Louisville Research Foundation Inc /ID# 232139
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center /ID# 226937
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital /ID# 230694
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System /ID# 226932
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4500
        • University of Mississippi Medical Center /ID# 232620
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Las Vegas Research Center /ID# 255631
    • New Jersey
      • Newark, New Jersey, United States, 07103-2842
        • North Jersey Community Research Initiative (NJCRI) /ID# 245129
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College /ID# 230815
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Coastal Research Institute, LLC /ID# 233233
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital /ID# 231204
      • Cincinnati, Ohio, United States, 45267-0585
        • University of Cincinnati /ID# 226922
    • Oklahoma
      • Tahlequah, Oklahoma, United States, 74464-0545
        • Cherokee Nation Outpatient Health Center /ID# 232618
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-4414
        • Thomas Jefferson University /ID# 232624
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology /ID# 233332
    • Tennessee
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 241282
    • Texas
      • Houston, Texas, United States, 77030-2783
        • Liver Associates of Texas, P.A /ID# 229775
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Sp /ID# 232633
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Wisconsin Medical Center /ID# 230116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV RNA at screening, and at least 1 of the following:

    • Negative anti-HCV antibody, HCV Ribonucleic Acid (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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks
Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.
Drug: Glecaprevir/Pibrentasvir (GLE/PIB)
Oral tablets
Other Names:
  • Mavyret
  • ABT-493/ABT-530

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population
Time Frame: 12 weeks after last dose of study drug (Week 20)
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 the study drug.
12 weeks after last dose of study drug (Week 20)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population.
Time Frame: 12 weeks after last dose of study drug (Week 20)
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 the study drug.
12 weeks after last dose of study drug (Week 20)
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population
Time Frame: Up to week 8
On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.
Up to week 8
Percentage of Participants With Post-Treatment Relapse in the ITT Population
Time Frame: Up to 12 weeks after the last dose of study drug (Week 20)
Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.
Up to 12 weeks after the last dose of study drug (Week 20)
Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population
Time Frame: Up to 12 weeks after the last dose of study drug (Week 20)
Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.
Up to 12 weeks after the last dose of study drug (Week 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2021

Primary Completion (Estimated)

September 16, 2024

Study Completion (Estimated)

September 16, 2024

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20-350
  • 2020-005777-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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