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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)

NCT01070550 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4680

Last updated 2016-06-15

Study results available
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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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Peginterferon alfa-2a (Pegasys®)

Peginterferon (PEG-IFN) alfa-2a Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Austria
  • Brazil
  • Canada
  • Croatia
  • France
  • Hungary
  • Mexico
  • Morocco
  • North Macedonia
  • Poland
  • Romania
  • Serbia
  • Slovenia
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070550 on ClinicalTrials.gov