CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 81 enrolled
Drug / intervention
Peginterferon alfa-2adrug
Likely dose
Peginterferon alfa-2a 135 mcg or 90 mcg SC once weeklyAI-extracted
Key inclusion· 5
  • ✓Serum HCV RNA quantifiable at >600 IU/mL
  • ✓Liver biopsy consistent with chronic hepatitis C within 2 years of enrollment
  • ✓Compensated liver disease without cirrhosis
  • ✓End-stage renal disease undergoing hemodialysis
Key exclusion· 8
  • ✕Prior interferon therapy at any time
  • ✕Liver cirrhosis
  • ✕Signs and symptoms of hepatocellular carcinoma
  • ✕Decompensated liver disease

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

Search/NCT02806505
NCT02806505Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis

Hoffmann-La Roche·interventional·Posted Jun 20, 2016·Updated Oct 31, 2016

In Brief

A Phase 3 clinical trial evaluating Peginterferon alfa-2a for Hepatitis C, Chronic. Completed, enrolled 81 participants across 22 sites in 8 countries.

Detailed Summary

This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustria, Brazil, France, Greece, Indonesia, Italy, Turkey (Türkiye), United Arab Emirates
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2016
Enrollment StartJun 1, 2004
Primary CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.0 years ago

Interventions

Peginterferon alfa-2adrug

Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.