CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 114 enrolled
Drug / intervention
Pegylated Interferon/ribavirindrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Age 5-18 years at enrollment (not yet 18th birthday at screening)
  • ✓HCV viremia documented on 2 separate tests at least 6 months apart
  • ✓Chronic liver disease with inflammation and/or fibrosis consistent with chronic hepatitis C on liver biopsy within past 24 months
  • ✓Compensated liver disease (Child-Pugh Grade A)
Key exclusion· 20
  • ✕Any prior treatment with interferon or ribavirin
  • ✕Investigational drug within 6 weeks prior to first dose of study drug
  • ✕Systemic antiviral therapy within 6 weeks prior to first dose (exception: acyclovir for herpes)
  • ✕Positive screening for anti-HAV IgM, HBsAg, anti-HBc IgM, or anti-HIV antibody

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

Search/NCT00100659
NCT00100659Phase 3Completed
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Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jan 5, 2005·Updated Oct 24, 2018

In Brief

A Phase 3 clinical trial evaluating Pegylated Interferon/ribavirin for Chronic Hepatitis C. Completed, enrolled 114 participants across 11 sites.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children. The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesUnited States
CollaboratorsRoche Pharma AG

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 5, 2005
Enrollment StartDec 1, 2004
Primary CompletionAug 1, 2008
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 21.5 years ago

Interventions

Pegylated Interferon/ribavirindrug