Trial information
APPROACH study: Outcomes Assessment of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis C (CHC).
Status: No longer recruiting
Protocol number: ML20090
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A prospective, open label study of the effect of PEGASYS and ribavirin on quality of life, resource use and clinical outcomes in patients with chronic hepatitis C
Brief summary: This study will examine quality of life, resource use and clinical outcomes (primarily sustained virological response) in patients with CHC eligible to receive treatment with commercially available PEGASYS and ribavirin. The anticipated time on study treatment is 24 weeks for patients with genotypes 2 and 3, and 48 weeks for non-genotypes 2 and 3 (with outcome assessments made 24 weeks after treatment). The target sample size is 500 individuals. Target sample size is 500.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: Sustained virological reponse Time frame:At end of treatment-free follow up.
Key secondary outcomes: Quality of life (SF-36), resource utilization, adverse events, labs. Time frame: Throughout study
Inclusion criteria:
- males or females, >= 18 years of age;
- CHC infection;
- eligible for, and scheduled to receive, treatment with commercially available PEGASYS and ribavirin.
Exclusion criteria:
- coinfection with hepatitis B or HIV;
- moderate hepatic failure, decompensated cirrhosis or hepatocellular cancer;
- known hypersensitivity to alfa interferons.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2006
Trial registration date: 05/04/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Calgary, AB
- Edmonton, AB
- Abbotsford, BC
- Surrey, BC
- Vancouver, BC
- Vernon, BC
- West Vancouver, BC
- Winnipeg, MB
- Barrie, ON
- Brampton, ON
- Downsview, ON
- Hamilton, ON
- Kingston, ON
- London, ON
- Mississauga, ON
- Newmarket, ON
- Oshawa, ON
- Ottawa, ON
- Richmond Hill, ON
- Sudbury, ON
- Thunder Bay, ON
- Toronto, ON
- Whitby, ON
- Windsor, ON
- Montreal, QC
- Quebec City, QC
- St-Charles Borromee, QC
- Regina, SK
