Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Parallel
  • Endpoints: Pharmacokinetics

Study Type:

Interventional

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: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Birmingham, AL 35294
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: August 20, 2008 at 2:16:40 PM


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