ClinicalTrials.gg
RecruitingNCT07419347Updated Apr 16, 2026

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

An observational study in Hepatitis C Virus (HCV), sponsored by AbbVie. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by AbbVie · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatitis C Virus (HCV)

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Keywords

  • Hepatitis C Virus (HCV)
  • Glecaprevir
  • Pibrentasvir
03

In context

Hepatitis C

1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 218 across 435 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Treated with DAAs other than G/P.
  • History of decompensated cirrhosis.
  • Had Hepatitis-B virus () infection.
  • Had hepatocellular carcinoma (HCC).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • Glecaprevir/Pibrentasvir

    Data from participants prescribed Glecaprevir/pibrentasvir will be collected.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Experiencing Adverse Events

    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.

    Time frame: Up to approximately 210 days

  2. Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN)

    ALT and AST levels will be assessed.

    Time frame: Up to approximately 210 days

  3. Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3x Upper Limit of Normal (ULN) With Total Bilirubin > 2x ULN

    ALT, AST and Bilirubin levels will be assessed.

    Time frame: Up to approximately 210 days

07

Study locations

2 of 2 sites recruiting
  • Vancouver Infectious Diseases Centre /ID# 275313
    Vancouver, British Columbia V6Z 2C7, Canada
    Recruiting
  • St. Clair Medical Clinic /ID# 275334
    Toronto, Ontario M4S 1Y2, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07419347
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Feb 27, 2026
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Apr 16, 2026

Study contacts

Dimitri Semizarov
Contact
dimitri.semizarov@abbvie.com
+1 847-935-8741
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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