Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC

Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC - Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006265

Enrollment

500

Registered

2011-09-01

Start date

2011-08-01

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 with compensated liver cirrhosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: #Diagnosis of CHC with compensated LC by the investigator #Positive serum HCV RNA

Exclusion criteria

Exclusion criteria: All contraindications specified in the Japanese package insert of PEGASYS/COPEGUS must be adhered. The major exclusion criteria are: #Coadministration of Shosaikoto #Autoimmune hepatitis #Severe hepatic dysfunction #Unstable or uncontrolled cardiac disease #Hypersensitivity to peginterferon or ribavirin or to any of the excipients #Pregnancy (A pregnancy needs to be reliably ruled out before treatment initiation and reliably prevented during treatment, please see the Japanese package insert for PEGASYS/COPEGUS for further details) #Breast-feeding women #Hemoglobinopathies (e.g. thalassemia, sickle-cell anemia)

Design outcomes

Primary

Measure	Time frame
Efficacy: HCV RNA unditectable at 24 weeks after treatment (sustained virological response, SVR)	—

Countries

Japan

Contacts

Public ContactAyaka Shimizu

Chugai Pharmaceutical Co., Ltd. Real World Data Science Dept.

shimizuayk@chugai-pharm.co.jp0332730905

Outcome results