A Phase 2 interventional study of Copegus and Copegus in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 66 sites in 10 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 413 is above 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:
RO5024048 500 mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Drug: Copegus · Drug: Pegasys · Drug: RO5024048
RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Drug: Copegus · Drug: Pegasys · Drug: RO5024048
RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Drug: Copegus · Drug: Pegasys · Drug: RO5024048
Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks
Drug: Copegus · Drug: Pegasys · Drug: RO5024048
Group 5 will receive SOC for 48 weeks
Drug: Copegus · Drug: Pegasys
Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks.
Drug: Copegus · Drug: Pegasys · Drug: RO5024048
1000/1200mg po daily for 24 or 48 weeks
1000/1200mg po daily for 48 weeks
180 micrograms sc weekly for 24 or 48 weeks
180 micrograms sc weekly for 48 weeks
1000mg bid for 24 weeks
500mg bid for 12 weeks
1000mg bid for 8 weeks
1000mg bid for 12 weeks
Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level
Time frame: 24 weeks after end of treatment
Virologic response: Percentage of patients with undetectable Hepatitis C RNA level
Time frame: 60 Weeks
Virologic response: Percentage of patients with undetectable Hepatitis C RNA level
Time frame: 12 weeks post-treatment
Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment
Time frame: 72 weeks
Safety: Incidence of adverse events
Time frame: 72 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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