NCT00245414

Trial of Pegasys® in Patients With Chronic Hepatitis C

Post-marketing Clinical Trial of Pegasys® 180μg for Subcutaneous Injection in Patients With Chronic Hepatitis C. General Clinical Study in Interferon (IFN)-Treated and IFN-untreated Chronic Hepatitis C Patients, Except for Those Infected With High Viral Load of Genotype 1b

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL). In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Pegasys®	180μg for s.c./week for 48 weeks
DRUG	Pegasys®	180μg for s.c./week for 24 weeks

Timeline

• Start date: 2005-10-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2005-10-28
• Last updated: 2010-11-17

Locations

6 sites across 1 country: Japan