Roche trials database

Trial information

A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis C (CHC).

Status:

Active, not recruiting

Protocol number:

ML17131

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

A randomized, open-label study of 2 different treatment durations of PEGASYS plus ribavirin on virological relapse in patients with chronic hepatitis C viral infection, genotype 1 or 4

Brief summary:

This study will compare the efficacy and safety of 2 different treatment durations of PEGASYS plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is >500 individuals. Target sample size is 731.

Study phase:

IV

Study type:

Interventional; Treatment; Non-randomized; Uncontrolled; Parallel; Safety/efficacy study

Conditions:

• Hepatitis C, Chronic

Intervention type:

Drug

Intervention name:

peginterferon alfa-2a [Pegasys]

Primary outcome:

1. Efficacy: Virologic relapse rates at end of follow-up period\n

Key secondary outcomes:

1. Efficacy: Virologic response rates Safety: AEs, laboratory values, vital signs. Safety: Adverse events, laboratory tests and vital signs.Quality of Life\n

Inclusion criteria:

• adult patients 18-65 years of age;
• CHC and genotype 1 (1a or 1b) or 4;
• liver biopsy findings within 6 months prior to study therapy consistent with CHC.

Exclusion criteria:

• previous interferon or PEGASYS plus ribavirin therapy;
• anti-neoplastic or immunomodulatory treatment <=6 months before study;
• medical condition associated with chronic liver disease other than CHC.

Gender:

Males or Females

Age limits:

Min: 18 years Max: 65 years

Accepts healthy volunteers:

No

Anticipated start date:

May, 2003

Trial registration date:

20.12.2005

Date last updated:

06.05.2013

This trial was conducted at the following locations:

Austria

• FELDKIRCH
• GRATWEIN
• GRAZ
• INNSBRUCK
• KREMS
• LINZ
• OBERNDORF
• OBERPULLENDORF
• RIED-INNKREIS
• SALZBURG
• VILLACH
• WELS
• WIEN
• WIENER NEUSTADT

Link to trial result