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

Not Applicable

• Conditions: HCV patients receiving hemodialysis

• Registration Number: JPRN-UMIN000030680
• Lead Sponsor: Tokai University School of Medicine, Department of Gastroenterology and Hepatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-04
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare erythropoietic resistance index change between pre and post of treatment

Secondary Outcome Measures

Name	Time	Method
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