Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) and COPEGUS (Ribavirin) Combination Therapy in Patients With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment.
Status: Completed
Protocol number: NP17355
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label pharmacokinetic study of single and multiple doses of combination therapy with PEGASYS and ribavirin in hemodialysis patients with moderate or severe renal impairment or end-stage renal disease
Brief summary: This study will evaluate the pharmacokinetics (AUC, Cmax) and the tolerability, of PEGASYS and ribavirin combination therapy following single and multiple doses in patients with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
48.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Pharmacokinetics: serum concentrations of PEGASYS and ribavirin. Pharmacodynamics: HCV-RNA
Key secondary outcomes: 1. Safety: Vital signs, laboratory values, clinical adverse events, ECG, dose modifications and premature withdrawals for safety reasons
Inclusion criteria:
- adult patients 18 to 65 years of age;
- CHC infection;
- 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;
- normal renal function, moderate or severe renal impairment, or ESRD;
- patients with ESRD must have been undergoing hemodialysis for >=2 months.
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;
- interferon or ribavirin treatment within the previous 3 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: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
France
New Zealand
Sweden
United States
- Birmingham, AL
- Kansas City, KS
- New Orleans, LA
- Kansas City, MO
- St Louis, MO
- New York, NY
- Syracuse, NY
- Cleveland, OH
- Portland, OR
- Pittsburgh, PA
- Dallas, TX
- Galveston, TX
