An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs

Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C Genotypes 1 to 6

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SoonChunHyang University CheonAn Hospital /ID# 209996, Cheonan-si, Chungcheongnam-do, South Korea

About this study

Patients with type C hepatitis genotypes 1-6 who had been prescribed Maviret (glecaprevir/pibrentasvir) in accordance with approved local label.

The sample size for this study is due to a requirement by local authorities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants with chronic C hepatitis genotypes 1 to 6.
Participants prescribed Maviret in accordance with approved local label.

Exclusion criteria

Patients with contraindications to the approved local labels for Maviret.

Treatment and study plan

Primary outcomes

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Time frame: 12 weeks after the last dose of study drug

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after end of treatment.

Secondary outcomes

Percentage of Participants With On-treatment Virologic Failure

Time frame: Up to 30 weeks

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ persistently during treatment period.
Percentage of Participants With Post-treatment Relapse

Time frame: Up to 28 weeks

Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the end of treatment among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the "Standard for Re-examination of New Drugs"

Acronym: Maviret PMS

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Nov 14, 2018
Registry last updated: Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed