Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by glecaprevir and pibrentasvir therapy in HCV-infected hemodialysis patients

Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by glecaprevir and pibrentasvir therapy in HCV-infected hemodialysis patients - Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by glecaprevir and pibrentasvir therapy in HCV-infected hemodialysis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030680

Enrollment

Registered

2018-01-04

Start date

2018-01-04

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

HCV patients receiving hemodialysis

Interventions

Patients will orally receive glecaprevir 300mg and pibrentasvir 120mg once daily for 8 or 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)20 years old or older 2)HCV-infected(genotype1,2,3,4,5,6) patients with hemodialysis 3)Patients who were provided with sufficient explanation before participating in this study and who provided written consent to participate in this study on their own free will.

Exclusion criteria

Exclusion criteria: 1)Patients with decompensated cirrhosis 2)Patients complicated with hepatocellular carcinoma 3)Patients with HBs antigen or anti-HIV antibody positive 4)Patients with a history of hypersensitivity to lecaprevir and pibrentasvir 5)Patients receiving atazanavir sulfate (Reyataz), atorvastatin calcium hydrate (Lipitor etc.), rifampicin (Rifazine etc.) 6)Other patients whom the chief investigator or a sub-investigators considers inappropriate

Design outcomes

Primary

Measure	Time frame
To compare erythropoietic resistance index change between pre and post of treatment	—

Secondary

Measure	Time frame
To assess Iron metabolism kinetics (hepcidin,ferritin,Fe,TIBC) To assess mineral-bone metabolism kinetics (FGF23,1.25D,25D,intactPTH) To assess antiviral activity, the proportion of subjects who achieve undetectable HCV RNA at post treatment week 12 To assess safety To assess CLDQ-HCV, KDQOL-SF	—

Countries

Japan

Contacts

Public ContactYoshitaka Arase

Tokai University Oiso Hospital Department of Gastroenterology and Hepatology

arase@tokai-u.jp0463-72-3211

Outcome results

None listed

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