NCT01066793

PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,343 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<2000.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a [Pegasys]	Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
DRUG	Peginterferon alfa-2b [PegIntron®]	Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2010-02-10
• Last updated: 2016-05-09
• Results posted: 2016-05-09

Locations

100 sites across 4 countries: Belgium, Ireland, Italy, United Kingdom