A Phase 4 interventional study of Copegus and Copegus in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 22 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-05.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. 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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 104 is close to the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Copegus · Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus · Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus · Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus · Drug: peginterferon alfa-2a [Pegasys]
1200-1600mg/day po
1000-1200mg/day po
360 micrograms sc weekly
180 micrograms sc twice weekly
Sustained viral response
Time frame: Week 72
Percentage of patients with >=2log drop of HCV-RNA
Time frame: Week 4, 12, 24.
Percentage of patients with non-detectable HCV-RNA
Time frame: Week 48
Relapse rate
Time frame: Throughout study.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche