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Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response

NCT04577482 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2023-08-14

No results posted yet for this study

Summary

Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.

GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.

Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

Conditions

  • Hepatitis C Virus (HCV)

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2022-09-03
Completion
2022-09-03

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577482 on ClinicalTrials.gov