CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Currently receiving opioid maintenance therapy
  • ✓Serologic evidence of chronic hepatitis C
  • ✓Hepatitis C genotype 2, 3, 1, or 4
Key exclusion· 4
  • ✕Harmful use of psychoactive substances or excessive alcohol consumption that would impair study participation
  • ✕Prior pegylated interferon, standard interferon, or ribavirin therapy
  • ✕Co-infection with hepatitis A, hepatitis B, or HIV
  • ✕Current diagnosis of major depression or any psychotic disorder

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

Search/NCT01416610
NCT01416610N/ACompleted
CompareCT.gov

A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life

Hoffmann-La Roche·observational·Posted Aug 15, 2011·Updated Apr 10, 2017

In Brief

An observational study for Hepatitis C, Chronic. Completed, enrolled 88 participants across 10 sites.

Detailed Summary

This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 15, 2011
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 14.9 years ago