Efficacy and safety of daclatasvir and asunaprevir in patients with chronic hepatitis C

Efficacy and safety of daclatasvir and asunaprevir in patients with chronic hepatitis C - Efficacy and safety of daclatasvir and asunaprevir

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015247

Enrollment

350

Registered

2014-09-25

Start date

2014-09-25

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 cirrhosis patients with HCV serogroup 1 3) Ineligible or intorelant patients, or non-responder for antiviral therapy including interferon 4) Eligible patients for daclatsvir and asunaprevir

Exclusion criteria

Exclusion criteria: 1) Co-infection with hepatitis B virus 2) Co-infection with anti-human immunodeficiency virus 3) Other forms of liver disease (alcohol liver disease, autoimmune hepatitis etc.) 4) Decompensated cirrhosis, Liver failure 5) Severe multisystem disease, Severe immunodeficiency 6) Pregnant woman 7) Contraindication to daclatasvir and asunaprevir

Design outcomes

Primary

Measure	Time frame
Sustained virologic response rate The factor associated with sustained virologic response Safety Emergence of drug-resistant virus Cumulative incidence of hepatocellular carcinoma 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