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Recruiting NCT07419347

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

— Observational Hepatitis C Virus (HCV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatitis C Virus (HCV). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Percentage of Participants Experiencing Adverse Events [Time frame: 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]
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 2 centers
  • Vancouver Infectious Diseases Centre /ID# 275313 — Vancouver
  • St. Clair Medical Clinic /ID# 275334 — Toronto

Identifiers

NCT: NCT07419347 · P25-554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗