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

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01659567
First received: July 27, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition
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)

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659567

Contacts
Contact: Reference Study ID Number: ML25544 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01659567     History of Changes
Other Study ID Numbers: ML25544
Study First Received: July 27, 2012
Last Updated: April 7, 2014
Health Authority: Georgia: State Agency for Regulation of Medical Activities of Georgia

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014