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An Observational Study of Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 27, 2012
Last updated: November 1, 2016
Last verified: November 2016
This prospective observational study will investigate predictive values of virological response in peginterferon/ribavirin treatment-naive patients with chronic hepatitis C. Patients will be treated with Pegasys (peg-interferon alpha 2a) and Copegus (ribavirin) as prescribed by the physician. Data will be collected for 72 weeks.

Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on Predictors of On-treatment Response and Sustained Virological Response in a Cohort of HCV-infected Patients Treated With Pegylated Interferons in Georgia

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Predictive values of sustained virological response [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Correlation of patient characteristics and sustained virological response [ Time Frame: 48 weeks ]
  • Overall treatment duration [ Time Frame: 48 weeks ]
  • Treatment duration after sustained virological response [ Time Frame: 48 weeks ]
  • Correlation of treatment dose and sustained virological response [ Time Frame: 48 weeks ]
  • Sustained virological response [ Time Frame: Week 24 ]
  • Safety: incidence of adverse events [ Time Frame: 72 weeks ]

Enrollment: 530
Study Start Date: April 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with chronic hepatitis C infection and naive to peginterferon/ribavirin treatment

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of chronic hepatitis C infection

Exclusion Criteria:

  • Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
  • Patients previously treated with peginterferon/ribavirin
  • Participation in another clinical study within 30 prior to study start of ML25544
  Contacts and Locations
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Please refer to this study by its identifier: NCT01659567

Tbilisi, Georgia, 0159
Tbilisi, Georgia, 0160
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01659567     History of Changes
Other Study ID Numbers: ML25544
Study First Received: July 27, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic processed this record on September 21, 2017