Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation

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

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-28

Study Completion Date

2020-09-04

Brief Summary

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This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.

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Detailed Description

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Conditions

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Chronic Hepatitis C (CHC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glecaprevir plus Pibrentasvir

Participants in this observational study will receive treatment with glecaprevir and pibrentasvir for up to 16 weeks for treatment of chronic hepatis C (CHC) genotypes 1, 2, 3, 4, 5, or 6.

The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice, international guidelines and/or label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
* May be enrolled up to 4 weeks after treatment initiation.
* Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.