Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Administered Alone or in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Have Participated in Previous PEGASYS Trials.

Status: Recruiting

Protocol Number: NV17590

Sponsor: Roche Global Development

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the safety of PEGASYS alone or in combination with ribavirin in patients with chronic hepatitis C who have participated in previous studies

Brief Summary: In this study, patients with CHC infection will receive PEGASYS alone or in combination with ribavirin. Patients who have received prior PEGASYS monotherapy or combination therapy or who were previously considered eligible for treatment with PEGASYS will be eligible to participate in this study. The anticipated time on study treatment is 3-12 months and the target sample size is open. Target sample size is 500.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety

Study Type:

Interventional

Condition: Hepatitis C, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. Safety: Serious adverse events, deaths, dose modifications, and premature withdrawals for safety reasons

Key Secondary Outcomes: 1. Overall ISR summary score; AEs and ISR leading to discontinuation; SAEs; deaths; patient satisfaction/preference; adherence.

Inclusion Criteria:

  • patients >=18 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;
  • previous participation in a study in which treatment or re-treatment with PEGASYS alone or in combination with ribavirin was recommended or deemed appropriate after study completion.

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.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2003

Trial Registration Date: 07/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Adelaide, Australia, 5000
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 1:54:36 PM


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