Farmington,
Connecticut
06030
Purpose:
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.
Criteria:
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.