A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

Status:	Completed
Conditions:	Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	January 2004
End Date:	December 2005

Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater Than 85 kg

The effects of treatment with different doses of PEGASYS in combination with different doses
of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer,
body weight greater than 85kg (187lbs) and no prior treatment with interferon. The
anticipated time on study treatment is 3-12 months and the target sample size is 100-500
individuals.

Inclusion Criteria:

- adult patients >=18 years of age;

- body weight >85kg (187lbs);

- CHC (genotype 1);

- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC
infection;

- use of 2 forms of contraception during study and 6 months after the study in both men
and women.

Exclusion Criteria:

- women who are pregnant or breastfeeding;

- male partners of women who are pregnant;

- conditions associated with decompensated liver disease;

- other forms of liver disease, including liver cancer;

- human immunodeficiency virus infection;

- previous treatment with an interferon, ribavirin, viramidine, levovirin or
amantadine.

We found this trial at

sites

Clinical Trial Facility in Gainesville Florida

Gainesville, Florida 32610

from

Gainesville, FL