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Evaluation of the efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients: a prospective study in real-life settings.

Evaluation of the efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients: a prospective study in real-life settings. - The efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019468
Enrollment
100
Registered
2015-11-01
Start date
2015-09-01
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

Interventions

sofosbuvir and ledipasvir combination tablets a fixed-dose combination tablet containing 90mg of ledipasvir and 400mg of sofobuvir orally, once daily for 12 weeks

Sponsors

Toranomon Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: chronic hepatitis C and compensated cirrhotic patients with HCV genotype 1 naive and DAA treatment experienced patients

Exclusion criteria

Exclusion criteria: decompensated cirrhosis coexisting heart disease renal impairment

Design outcomes

Primary

MeasureTime frame
sustained virological response (SVR) at 12 week and 24 week after the end of treatment

Secondary

MeasureTime frame
incidence rate of adverse events

Countries

Japan

Contacts

Public ContactHitomi Sezaki

Toranomon Hospital hepatology

hitomis@mx1.harmonix.ne.jp03-3588-1111

Outcome results

None listed

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