Idenix Pharmaceuticals (IDIX)

[gofishmarko]

Roche megadose non-responder study

( I think Roche wants to capture as much of the non-responder market as possible before competitors butt in , and side-effects be damned ! )

TITAN Study: A Study of PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1

This study is not yet open for patient recruitment.
Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412334

Purpose
This study will evaluate the efficacy and safety of 4 regimens of PEGASYS® plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS® plus ribavirin. Patients will be randomized to one of 4 groups, to receive

a)PEGASYS® 360µg/week plus Copegus 1000-1200mg/day, b)PEGASYS® 180µg twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS® 360µg/week plus Copegus 1200-1600mg/day, or d)PEGASYS® 180µg twice weekly plus Copegus 1200-1600mg/day. ( OUCH! )

Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.