NCT01447446

An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,442 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Peg-IFN Alfa-2a	Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
DRUG	Peg-IFN Alfa-2b	Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
DRUG	Ribavirin	Ribavirin according to standard of care and in line with local labeling.
DRUG	Boceprevir	Boceprevir according to standard of care and in line with local labeling.
DRUG	Telaprevir	Telaprevir according to standard of care and in line with local labeling.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-10-06
• Last updated: 2017-03-30
• Results posted: 2017-03-30

Locations

271 sites across 27 countries: Belgium, 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