CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 57 enrolled
Drug / intervention
Ribavirin +1 moredrug
Likely dose
Pegasys 180 micrograms intravenously/subcutaneously weekly plus ribavirin 1000–1200 mg orally twice daily for 36–60 weeksAI-extracted
Key inclusion· 3
  • ✓Age ≥18 years
  • ✓Chronic HCV infection, genotype 1
  • ✓Failed or unable to tolerate PEG-Intron plus ribavirin after 12 weeks of prior therapy
Key exclusion· 4
  • ✕Pregnant or breast-feeding women
  • ✕Medical conditions associated with chronic liver disease (hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
  • ✕Decompensated cirrhosis
  • ✕Systemic antiviral therapy or investigational drugs other than PEG-Intron plus ribavirin within 24 weeks of study entry

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

Search/NCT00087568
NCT00087568Phase 4Completed
CompareCT.gov

An Open-label, Multicenter, Efficacy and Safety Study of Pegasys® Plus Ribavirin in Patients With Chronic HCV Infection Who Are Unable to Tolerate or Who Do Not Respond to 12 Weeks of Therapy With PEGIntron ® Plus Ribavirin

Hoffmann-La Roche·interventional·Posted Jul 14, 2004·Updated Jun 8, 2016

In Brief

A Phase 4 clinical trial evaluating Ribavirin and peginterferon alfa-2a [Pegasys] for Hepatitis C, Chronic. Completed, enrolled 57 participants across 25 sites.

Detailed Summary

This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2004
Enrollment StartJan 1, 2003
Primary CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 22.0 years ago

Interventions

Ribavirindrug

1000/1200mg po bid for 36 or 60 weeks

peginterferon alfa-2a [Pegasys]drug

180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)