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 (Maviret PMS)

AbbVie

Status: Completed

Conditions: Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT03740230

P19-423

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,134 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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.

Trial design

3,134 participants in 1 patient group

Hepatitis C

Description:

Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks.