Trial Information

Summary: EAP (Expanded Access Program). A Study of PEGASYS (Peginterferon alfa-2a (40KD))Monotherapy and Combination Therapy With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC).

Status: No longer recruiting

Protocol Number: BV16209

Sponsor: F Hoffmann-La Roche Ltd./Inc/AG/Roche Global Business

Company Division: Pharmaceutical

Official Scientific Title: An expanded-access, open-label study of the safety and tolerability of PEGASYS alone and in combination with ribavirin in patients with chronic hepatitis C.

Brief Summary: This Expanded Access Program will assess the safety and tolerability of treatment with PEGASYS alone or in combination with ribavirin in patients with CHC. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 10900.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • 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. Safety: Adverse event rate and profile

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

Inclusion Criteria:

  • adult 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 contraceptive methods during 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;
  • patients who did not respond to previous interferon or interferon plus ribavirin therapy;
  • 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: August, 2000

Trial Registration Date: 07/26/2005

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Dee Why, Australia, 2099
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 2:39:25 PM


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