Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection

Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection - Grazoprevir/Elbasvir therapy for hemodialyzed patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025784

Enrollment

Registered

2017-01-21

Start date

2017-01-21

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

hemodialyzed patients with chronic hepatitis C infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: hemodialyzed patients with genotype 1 chronic hepatitis C, who initiated on Grazoprevir/Elbasvir and asunaprevir between January 2017 and march 2019

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 the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors) 6 Patients with albumin <3.0 g/dL 7 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	—

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