CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 569 enrolled
Drug / intervention
Ribavirin +3 moredrug
Likely dose
Peginterferon alfa-2a 180 micrograms subcutaneously once weekly plus ribavirin 1000–1200 mg orally daily for 48 weeksAI-extracted
Key inclusion· 6
  • ✓Age 18–65 years
  • ✓Chronic hepatitis C, genotype 1
  • ✓Serologic evidence of CHC infection by antibody test
  • ✓Liver biopsy within past 18 months consistent with CHC infection
Key exclusion· 5
  • ✕Previous interferon or ribavirin therapy
  • ✕Systemic antiviral therapy within 24 weeks before first dose or expected need during study
  • ✕Medical conditions associated with chronic liver disease (hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
  • ✕Decompensated liver disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00107653
NCT00107653Phase 4Completed
CompareCT.gov

A Prospective, Multicenter, Open-label, Comparative, Efficacy Study of Pegasys® Plus Copegus® in Treatment-naïve Latino Patients With Chronic Hepatitis C-genotype 1, as Compared to Treatment-naïve Non- Latino Caucasian Patients With Chronic Hepatitis C-genotype 1

Hoffmann-La Roche·interventional·Posted Apr 7, 2005·Updated Jun 21, 2016

In Brief

A Phase 4 clinical trial evaluating Ribavirin and Peginterferon alfa-2a for Hepatitis C, Chronic. Completed, enrolled 569 participants across 60 sites in 2 countries.

Detailed Summary

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 7, 2005
Enrollment StartOct 1, 2004
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 21.2 years ago

Interventions

Ribavirindrug

1000-1200mg po daily for 48 weeks

Peginterferon alfa-2adrug

180 micrograms sc/week for 48 weeks

Ribavirindrug

1000-1200mg po daily for 48 weeks

Peginterferon alfa-2adrug

180 micrograms sc/week for 48 weeks