An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 11, 2011
Last updated: July 1, 2015
Last verified: July 2015
This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.

Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correlation of sustained virological response (SVR: undetectable HCV RNA 24 weeks after end of treatment) with rapid and early virological response [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of baseline host factors and virological response (HCV RNA levels) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Correlation of cumulative Pegasys/ribavirin dose and sustained virological response (SVR) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Relapse rate 24 weeks post-treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 443
Study Start Date: May 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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
Patients with chronic hepatitis C treated with Pegasys and ribavirin

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Serologically confirmed chronic hepatitis C (all genotypes)
  • Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion Criteria:

  • Coinfection with HIV and/or hepatitis B
  • Contraindications according to the SPC for Pegasys/ribavirin
  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: NCT01392742

Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1612
Sofia, Bulgaria, 1407
Stara Zagora, Bulgaria, 6000
Varna, Bulgaria, 9010
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01392742     History of Changes
Other Study ID Numbers: ML25670
Study First Received: July 11, 2011
Last Updated: July 1, 2015
Health Authority: Bulgaria: Bulgarian Drug Agency

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
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015