CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,442 enrolled
Drug / intervention
Peg-IFN Alfa-2a +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01447446
NCT01447446N/ACompleted

Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C

Hoffmann-La Roche·observational·Posted Oct 6, 2011·Updated Mar 30, 2017

In Brief

An observational study evaluating Peg-IFN Alfa-2a, Peg-IFN Alfa-2b, and 3 other interventions for Hepatitis C, Chronic. Completed, enrolled 4,442 participants across 271 sites in 27 countries.

Detailed Summary

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Kuwait, Lebanon, Morocco, North Macedonia, Oman, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Sweden, Switzerland, Syria, Taiwan, Turkey (Türkiye), United Arab Emirates, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2011
Enrollment StartSep 1, 2011
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.7 years ago

Interventions

Peg-IFN Alfa-2adrug

Peg-IFN Alfa-2a according to standard of care and in line with local labeling.

Peg-IFN Alfa-2bdrug

Peg-IFN Alfa-2b according to standard of care and in line with local labeling.

Ribavirindrug

Ribavirin according to standard of care and in line with local labeling.

Boceprevirdrug

Boceprevir according to standard of care and in line with local labeling.

Telaprevirdrug

Telaprevir according to standard of care and in line with local labeling.