PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peginterferon alfa-2a (Pegasys®)

Study type: Observational

Funder types: Industry

Identifiers

NCT01070550

MV21012

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) 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 <5000.

Enrollment: 4,680 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 Hepatitis B Virus (HBV)
• previous treatment with peginterferon and/or ribavirin

Trial design

4,680 participants in 1 patient group

Cohort

Description:

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

Treatment:

Drug: Peginterferon alfa-2a (Pegasys®)