Safety and efficacy of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients with chronic hepatitis or liver cirrhosis

Safety and efficacy of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients with chronic hepatitis or liver cirrhosis - glecaprevir/pibrentasvir for patients with HCV

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031090

Enrollment

300

Registered

2018-01-31

Start date

2017-12-15

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

patients with HCV infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with chronic hepatitis C, who initiated on glecaprevir/pibrentasvir between November 2017 and march 2024

Exclusion criteria

Exclusion criteria: 1) Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A inhibitors 2) Patients with serious liver dysfunction (Child-Pugh Class B or C) 3) Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia) 4) Patients who have malignant tumors, including hepatoma, at the start of treatment 5) Patients on treatment with drugs listed in the contraindications for coadministration in thepackage insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors) 6) Other patients judged to be inappropriate to participate in the study by the primary physician

Design outcomes

Primary

Measure	Time frame
Sustained virological response adverse events	—

Secondary

Measure	Time frame
1) efficacy and safety in patients with or without LC 2) efficacy and safety according to HCV genotype 3) association of RAVs and SVR 4) efficacy and safety in patients who previously failed to DAAs 5) efficacy and safety according to renal function. (including hemodialysis patients) 6) RAVs in patients failed to GP therapy 7) improvement of liver function after SVR. 8) improvement of AFP value 9) changes in lipid and glucose metabolism 10) improvement of renal function after HCV eradication 11) adverse events	—

Measure

Time frame

1) efficacy and safety in patients with or without LC 2) efficacy and safety according to HCV genotype 3) association of RAVs and SVR 4) efficacy and safety in patients who previously failed to DAAs 5) efficacy and safety according to renal function. (including hemodialysis patients) 6) RAVs in patients failed to GP therapy 7) improvement of liver function after SVR. 8) improvement of AFP value 9) changes in lipid and glucose metabolism 10) improvement of renal function after HCV eradication 11) adverse events

—

Countries

Japan

Contacts

Public ContactGoki Suda

Graduate School of Medicine, Hokkaido University Department of Gastroenterology and Hepatology

gsudgast@pop.med.hokudai.ac.jp011-716-2111

Outcome results