Trial of Pegasys® in Patients With Chronic Hepatitis C
NCT00245414 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2010-11-17
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
- DRUG
-
Pegasys®
180μg for s.c./week for 48 weeks
- DRUG
-
Pegasys®
180μg for s.c./week for 24 weeks
Sponsors & Collaborators
-
Chugai Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Ken Kashima · Chugai Pharmaceutical
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-10-31
- Primary Completion
- 2010-07-31
- Completion
- 2010-07-31
Countries
- Japan
Study Locations
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