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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-07

Study Completion Date

2022-09-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C Virus (HCV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants treated with Glecaprevir/Pibrentasvir

Participants will receive glecaprevir/pibrentasvir (GLE/PIB) as prescribed by physician in accordance with local clinical practice.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label.
* Participants can enroll up to 4 weeks after starting treatment