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

Hepatitis C, Chronic Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070550
• Other study ID #: MV21012
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: November 2, 2015
• Start date: June 2007
• Est. completion date: July 2011

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4598
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
As prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Brazil,  Canada,  Croatia,  France,  Hungary,  Macedonia, The Former Yugoslav Republic of,  Mexico,  Morocco,  Poland,  Romania,  Serbia,  Slovenia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive values of virological response 4 and 12 weeks after treatment initiation on sustained virological response (SVR) by HCV genotype		weeks 4 and 12, and 24 weeks after end of treatment	No
Secondary	Identification and confirmation of host-, virus- and treatment-related factors influencing viral response, SVR and relapse		throughout treatment and 12 and 24 weeks after end of treatment	No
Secondary	Correlation between overall treatment duration/treatment duration after HCV RNA becomes negative and SVR by genotype		assessed 12 and 24 weeks after end of treatment	No
Secondary	Correlation of cumulative ribavirin and peginterferon dose with SVR by genotype		assessed 12 and 24 weeks after end of treatment	No