NCT02118597

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

Non-interventional Study to Observe Triple Combination Therapy With Boceprevir or Simeprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary (IMPERIAL)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Boceprevir	Boceprevir administered according to corresponding summary of product characteristics (SmPC).
DRUG	Simeprevir	Simeprevir administered according to corresponding summary of product characteristics (SmPC).
DRUG	Pegylated Interferon (Peginterferon) Alfa-2a	Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).
DRUG	Ribavirin	Ribavirin according to corresponding summary of product characteristics (SmPC).

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-04-21
• Last updated: 2016-12-12
• Results posted: 2016-12-12

Locations

7 sites across 1 country: Hungary