Trial information
PINGU study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Plus Ribavirin in Early Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1/4/5/6
Status: No longer recruiting
Protocol number: ML18232
Sponsor: N.V. Roche S.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label pilot study of dose escalation of PEGASYS on virological response in patients with chronic hepatitis C viral infection showing an early non-response to a standard course of PEGASYS plus ribavirin
Brief summary: This study will evaluate the efficacy and safety of increasing the dose of PEGASYS in patients with CHC and an early non-response to a standard course of PEGASYS plus ribavirin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 75.
Study phase: II
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: 1. Efficacy: Virologic response rate at Week 12
Key secondary outcomes: 1. Efficacy: Sustained virologic response rate, EoT response rate, mean reduction in HCV-RNA at Weeks 2, 4, and 8
Safety: Discontinuation rate, adverse events, hemoglobin, and laboratory tests
Inclusion criteria:
- adult patients >=18 years of age;
- CHC infection;
- previously naive to therapy, and undergoing current treatment with PEGASYS plus ribavirin for 16 weeks without a positive effect;
- compensated liver disease.
Exclusion criteria:
- anti-viral, anti-neoplastic, or immunomodulatory treatment, other than PEGASYS, plus ribavirin <=6 months before study drug;
- medical condition associated with chronic liver disease other than CHC infection;
- co-infection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2005
Trial registration date: 08/29/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Antwerpen
- Brugge
- Bruxelles
- Charleroi
- Edegem
- Gent
- Liege
- Namur
- Yvoir
