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: October 13, 2014
Last verified: October 2014

This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receivi ng Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from pa tients 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, 1431
Sofia, Bulgaria, 1612
Sofia, Bulgaria, 1407
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1606
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: October 13, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs processed this record on October 19, 2014