CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 385 enrolled
Drug / intervention
Ribavirin +3 moredrug
Likely dose
Peginterferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin 1000–1200 mg/day orally, OR peginterferon alfa-2b 1.5 micrograms/kg subcutaneously weekly plus ribavirin 1000–1200 mg/day orallyAI-extracted
Key inclusion· 3
  • ✓Adult patients at least 18 years of age
  • ✓Chronic hepatitis C infection, genotype 1
  • ✓Interferon-naïve (no prior systemic antiviral or immunomodulatory therapy)
Key exclusion· 4
  • ✕Previous systemic therapy with antiviral, antineoplastic, or immunomodulatory agents
  • ✕Medical conditions associated with chronic liver disease (hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
  • ✕Decompensated liver disease
  • ✕Pregnancy or breastfeeding

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

Search/NCT00087607
NCT00087607Phase 4Completed
CompareCT.gov

A Prospective, Randomized, Open-label Study Evaluating the Viral Kinetics and Pharmacokinetics of Pegasys® Plus Copegus® and PEG-Intron® Plus Rebetol® in Interferon-naïve Patients With Chronic Hepatitis C.

Hoffmann-La Roche·interventional·Posted Jul 14, 2004·Updated Jul 1, 2016

In Brief

A Phase 4 clinical trial evaluating Ribavirin, Peginterferon alfa-2b (PEG-Intron), and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 385 participants across 41 sites.

Detailed Summary

This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Details

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

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2004
Enrollment StartJan 1, 2004
Primary CompletionMar 1, 2006
Study CompletionApr 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 22.0 years ago

Interventions

Ribavirindrug

1000/1200mg/day po

Peginterferon alfa-2b (PEG-Intron)drug

1.5 micrograms/kg sc weekly

Ribavirindrug

1000/1200mg/day po

Peginterferon alfa-2a [Pegasys]drug

180 micrograms sc weekly