Bioanalysis , Effect and safety of DCV/ASV in hemodialysis patients infected with HCV: Pilot Study

Bioanalysis , Effect and safety of DCV/ASV in hemodialysis patients infected with HCV: Pilot Study - PK study of DCV/ASV in hemodialysis patients infected with HCV:

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015539

Enrollment

Registered

2014-10-28

Start date

2014-11-01

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

Chronic hepatitis C in hemodialysis

Interventions

The DCV and ASV level in the blood during DCV/ASV dual treatment will be determined in hemodialysis patients infected with HCV.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hemodialysis patients infected with HCV and expected to survive for more than 5 years

Exclusion criteria

Exclusion criteria: 1) Autoimmune hepatitis 2) History of hypersensitivity to DCV and ASV 3) Decompenstated liver cirrhosis 4) HCC, malignat tumor 5) Pregnant or lactating women and women who may be pregnant 6) Judged by investigator not to be appropriate for inclusion in this study

Design outcomes

Primary

Measure	Time frame
Caluculated PK parameters such as Cmax, Cmin, Tmax, AUC at 1 week	—

Secondary

Measure	Time frame
sustend virologic response and virologic response at 1,2,3,4weeks Safety ( moniterd clinical and laboratory evaluation)	—

Countries

Japan

Contacts

Public ContactYoshiiku Kawakami

graduate school of biomedical science, Hiroshima university Department and medicine and molecular science

kamy4419@hiroshima-u.ac.jp082-257-5190

Outcome results

None listed

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