Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 27, 2012
Last updated: February 5, 2015
Last verified: February 2015

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of patient characteristics and sustained virological response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Overall treatment duration [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Treatment duration after sustained virological response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Correlation of treatment dose and sustained virological response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Sustained virological response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01659567

Contact: Reference Study ID Number: ML25544 888-662-6728 (U.S. Only)

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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01659567     History of Changes
Other Study ID Numbers: ML25544
Study First Received: July 27, 2012
Last Updated: February 5, 2015
Health Authority: Georgia: State Agency for Regulation of Medical Activities of Georgia

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases processed this record on February 27, 2015