A multicenter phase II study assessed safety and efficacy of asunaprevir and daclatasvir in patients with chronic hepatitis C virus genotype 1 infection and end-stage renal disease requiring hemodialysis

A multicenter phase II study assessed safety and efficacy of asunaprevir and daclatasvir in patients with chronic hepatitis C virus genotype 1 infection and end-stage renal disease requiring hemodialysis - A phase II study of asunaprevir and daclatasvir in patients requiring hemodialysis with chronic hepatitis C

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015882

Enrollment

Registered

2014-12-10

Start date

2014-12-15

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

Chronic hepatitis C with end-stage renal disease requiring hemodialysis

Interventions

Asunaprevir 200mg twice daily and daclatasvir 60mg once daily for 24 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing chronic hemodialysis. 2) Patients with chronic hepatitis or compensated cirrhosis infected with hepatitis C virus genotype 1.

Exclusion criteria

Exclusion criteria: 1) Patients who have malignant neoplasm, including hepatocellular carcinoma. 2) Patients with decompensated cirrhosis.

Design outcomes

Primary

Measure	Time frame
Sustained virological response at 12 weeks post-treatment.	—

Countries

Japan

Contacts

Public ContactTaiga Otsuka

Saga University Hospital Hepatology Division

otsuka-t@umin.ac.jp0952-34-2362

Outcome results

None listed

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