Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin in patients with chronic hepatitis C

Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin in patients with chronic hepatitis C - Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012183

Enrollment

500

Registered

2013-11-01

Start date

2013-12-01

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

Simeprevir with pegylated interferon alfa and ribavirin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with 20 years of age and older 2) Naive patients with HCV egnotype 1 with viral load of more than 5 log IU/ml 3) Treatment-experienced patients with HCV egnotype 1 4) Eligible patients for interferon and ribavirin

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) Contraindication to pegylated interferon 7) Contraindication to ribabirin

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

None listed

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