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

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peginterferon alfa-2b [PegIntron®]; Drug: Peginterferon alfa-2a [Pegasys]

Study type: Observational

Funder types: Industry

Identifiers

NCT01066793

MV21020

Details and patient eligibility

About

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.

Enrollment: 2,343 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >/= 18 years of age
• chronic hepatitis C
• informed consent to data collection

Exclusion criteria

• co-infection with HIV or HBV
• previous treatment with peginterferon and/or ribavirin

Trial design

2,343 participants in 1 patient group

Cohort

Description:

Participants chronically infected with the hepatitis C virus including genotypes 1 to 6

Treatment:

Drug: Peginterferon alfa-2b [PegIntron®]

Drug: Peginterferon alfa-2a [Pegasys]