Trial Information

Summary: 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

Protocol Number: NV17318

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of PEGASYS and ribavirin combination therapy on viral kinetics and virologic response in interferon-naïve patients with chronic hepatitis C genotype 1 infection

Brief Summary: 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. Target sample size is 160.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Hepatitis C, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD) [PEGASYS]

Primary Outcome: 1. Viral response compared to baseline Time frame: Week 24

Key Secondary Outcomes: 1. SVR and end of treatment virological response Time frame: Week 48 2. Virological response Time frame: Week 60 3. AEs, laboratory parameters, vital signs, Beck Depression Inventory Time frame: Throughout study

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.

Gender: Males or Females

Age Limits: Min: 18 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:
La Jolla, CA 92037
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: August 20, 2008 at 2:20:49 PM


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