Retrospective cohort study of resistance associated substitutions and clinical course in Glecaprevir(GLE)/Pibrentasvir(PIB) treatment to hepatitis C virus

Retrospective cohort study of resistance associated substitutions and clinical course in Glecaprevir(GLE)/Pibrentasvir(PIB) treatment to hepatitis C virus - RASs and clinical course in GLE/PIB treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027428

Enrollment

700

Registered

2017-11-01

Start date

2017-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hepatitis C virus infected patients

Interventions

Glecaprevir(GLE)/Pibrentasvir(PIB) are prescribed according to approved regimen(8 weeks or 12 weeks).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients were 20 years old and over patients treated with Glecaprevir and Pibrentasvir treatment.

Exclusion criteria

Exclusion criteria: Patients coinfection with human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease are excluded. Patients with uncontrollable other disease and those with alcohol abuse are also excluded.

Design outcomes

Primary

Measure	Time frame
The resistance associated substitutions were studied before pre-treatment and non-response or viral breakthrough.	—

Secondary

Measure	Time frame
HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests were also performed to evaluate the clinical course.	—

Countries

Japan

Contacts

Public ContactHideki Fujii

Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology

fuhideki@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026