Efficacy and safety of ledipasvir and sofosbuvir in patients with chronic hepatitis C

Efficacy and safety of ledipasvir and sofosbuvir in patients with chronic hepatitis C - Efficacy and safety of ledipasvir and sofosbuvir

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018561

Enrollment

2000

Registered

2015-08-06

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

Patients with chronic hepatitis C virus infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with 20 years of age and older 2) Chronic hepatitis or compensated cirrhosis patients with HCV serogroup 1 3) Eligible patients for ledipasvir and sofosbuvir

Exclusion criteria

Exclusion criteria: 1) Severe multisystem disease, Severe immnodeficiency 2) Patients with chronic renal failure or patients with hemodialysis 3) Contraindication to ledipasvir or sofosbuvir 4) Contraindication to ledipasvir and sofosbuvir

Design outcomes

Primary

Measure	Time frame
Sustained virologic response rate Safety Cumulative incidence of hepatocellular carcinoma	—

Secondary

Measure	Time frame
The factor associated with sustained virologic response Emergence of drug-resistant virus The factor associated with incidence of hepatocellular carcinoma	—

Countries

Japan

Contacts

Public ContactRyotaro Sakamori

Osaka University Graduate School of Medicine Gastroenterology and Hepatology

sakamori@gh.med.osaka-u.ac.jp81-6-6879-3621

Outcome results