PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2008
End Date:June 2011

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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

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.


Inclusion Criteria:

- adult patients, >/= 18 years of age

- chronic hepatitis C

- HIV HCV co-infection allowed

- informed consent to data collection

Exclusion Criteria:

- co-infection with HBV

- previous treatment with peginterferon and/or ribavirin
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Fayetteville, North Carolina 28304
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Charlotte, North Carolina 28207
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Egg Harbour Township, New Jersey 08234
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Huntington, West Virginia 25701
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