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Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients

Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients - Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024261
Enrollment
120
Registered
2016-10-03
Start date
2016-10-01
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

genotype 1 HCV patients receiving hemodialysis

Interventions

The subjects will be randomly assigned to the early intervention group and waiting intervention group. After entry in the study, the early intervention group will orally receive ASV 100 mg per dose tw

Sponsors

Department of Gastroenterology and Hepatology, Tokai University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)20 years old or older 2)Genotype 1 HCV -infected patients receiving 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 hepatic cancer 3)Other patients whom the chief investigator or a sub-investigators considers inappropriate

Design outcomes

Primary

MeasureTime frame
To compare erythropoietic resistance index change between pre and post of treatment in the early intervention group and waiting intervention group

Secondary

MeasureTime frame
To assess Iron metabolism kinetics To assess mineral-bone metabolism kinetics 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