Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
Status: | Completed |
---|---|
Conditions: | Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | August 2004 |
End Date: | February 2008 |
An Open-label Study of PEGASYS Plus Ribavirin on Sustained Virological Response in Treatment-naïve Latino White Patients Compared With Non-Latino Caucasian Patients With Chronic Hepatitis C, Genotype 1
This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc
weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus
non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on
study treatment is 3-12 months and the target sample size is 500+ patients.
weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus
non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on
study treatment is 3-12 months and the target sample size is 500+ patients.
Inclusion Criteria:
- adult patients 18-65 years of age
- CHC, genotype 1
- serologic evidence of CHC infection by an antibody test
- chronic liver disease, consistent with CHC infection on a liver biopsy obtained
within the past 18 months
- compensated liver disease
- use of 2 forms of contraception during the study in both men and women
Exclusion Criteria:
- previous interferon or ribavirin therapy
- systemic antiviral therapy less than 24 weeks before first dose of study drug or
expected need for this treatment any time during the study
- medical condition associated with chronic liver disease (eg, hemochromatosis,
autoimmune hepatitis, alcoholic liver disease, toxin exposure)
- decompensated liver disease
- women who are pregnant or breastfeeding
We found this trial at
50
sites
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
