Study of Glecaprevir/Pibrentasvir to Assess Safety Through Real-World Data

April 15, 2026 updated by: AbbVie

Retrospective Analysis of Glecaprevir/Pibrentasvir Safety and Concomitant Medications Through Integrated Real-World Data

The objective of this study is to assess the safety, tolerability and effectiveness of 8-week Glecaprevir/Pibrentasvir (G/P) in participants taking either prescribed or illicit drugs.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Recruiting
        • Vancouver Infectious Diseases Centre /ID# 275313
    • Ontario
      • Toronto, Ontario, Canada, M4S 1Y2
        • Recruiting
        • St. Clair Medical Clinic /ID# 275334

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with HCV prescribed 8 weeks of Glecaprevir/Pibrentasvir irrespective of participation in this study.

Description

Inclusion Criteria:

  • Prescribed 8 weeks of Glecaprevir/Pibrentasvir (G/P).
  • Treatment-naïve (for the current infection, participants that may have had prior infections which were resolved with treatment are considered naive for current infection as long as they have not received any treatment for the current infection.)
  • Is concomitantly on one or more prescription medications or illicit drugs.

Exclusion Criteria:

  • Treated with DAAs other than G/P.
  • History of decompensated cirrhosis.
  • Had Hepatitis-B virus (HBV) infection.
  • Had hepatocellular carcinoma (HCC).

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

Cohorts and Interventions

Group / Cohort
Glecaprevir/Pibrentasvir
Data from participants prescribed Glecaprevir/pibrentasvir will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Adverse Events
Time Frame: Up to approximately 210 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately 210 days
Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN)
Time Frame: Up to approximately 210 days
ALT and AST levels will be assessed.
Up to approximately 210 days
Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3x Upper Limit of Normal (ULN) With Total Bilirubin > 2x ULN
Time Frame: Up to approximately 210 days
ALT, AST and Bilirubin levels will be assessed.
Up to approximately 210 days

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)

February 27, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P25-554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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