Trial information

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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study

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 Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: October, 2003

Trial registration date: 07/26/2005

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Australia

• Adelaide
• Brisbane

Brazil

• Ribeirão Preto
• Salvador
• Sao Paulo

France

• Clichy
• Creteil
• Paris
• Pessac
• Vandoeuvre-Les-Nancy

Germany

• Berlin
• Frankfurt Am Main
• Freiburg
• Hamburg
• Hannover
• Köln

Italy

• Bologna
• Napoli
• Torino

Taiwan

• Taoyuan

United Kingdom

• Plymouth

United States

• Birmingham, AL
• La Jolla, CA
• Long Beach, CA
• San Diego , CA
• San Francisco, CA
• Aurora, CO
• Gainesville, FL
• Jacksonville, FL
• Miami, FL
• Orlando, FL
• Sarasota , FL
• Wellington, FL
• Atlanta, GA
• Honolulu, HI
• Indianapolis , IN
• Iowa City, IA
• Kansas City, KS
• Baltimore, MD
• Binghamton, NY
• Manhasset, NY
• New York, NY
• Charlotte, NC
• Durham, NC
• Cleveland, OH
• Portland, OR
• Lancaster, PA
• Philadelphia, PA
• Ponce, PR
• San Juan, PR
• Santurce, PR
• Providence, RI
• Germantown, TN
• Houston, TX
• Charlottesville, VA
• Bellevue, WA
• Seattle, WA
• Tacoma, WA