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 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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03740230

Acronym

Maviret PMS

Enrollment

3134

Registered

2018-11-14

Start date

2018-09-26

Completion date

2023-07-21

Last updated

2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, Chronic Hepatitis C, Genotypes, Genotypes 1 to 6, Maviret, Glecaprevir, Pibrentasvir

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	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

Measure	Time frame	Description
Percentage of Participants With On-treatment Virologic Failure	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	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.

Countries

South Korea

Outcome results