Trial information
A Study of the Pharmacokinetics of PEGASYS (Peginterferon alfa-2a (40KD)) and COPEGUS (Ribavirin) in Patients From Different Ethnic Backgrounds Infected With Chronic Hepatitis C (CHC)
Status: Completed
Protocol number: NP17354
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of PEGASYS and ribavirin in black, Hispanic, and white patients with chronic hepatitis C
Brief summary: This study will evaluate the pharmacokinetics (AUC, Cmax) of PEGASYS and ribavirin in Blacks, Hispanics, and Caucasians with CHC infection. The anticipated time on study treatment is <3 months and the target sample size is <100 individuals.
Target sample size is 45.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Pharmacokinetics study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Pharmacokinetics: Plasma ribavirin concentrations, serum PEGASYSî concentrations
Key secondary outcomes: 1. Safety: Vital signs, laboratory values, clinical adverse events, ECG, dose modifications, premature withdrawals from treatment
Inclusion criteria:
- black and Hispanic patients;
- adult patients, 18 to 65 years of age;
- CHC infection (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 (HIV) infection;
- treatment with interferon or ribavirin within previous 6 months.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Orlando, FL
- Kansas City, KS
- Baltimore, MD
- Tacoma, WA
