An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin
This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392742
First received: July 11, 2011
Last updated: June 11, 2013
Last verified: June 2013
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Purpose
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.
| Condition |
|---|
|
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 ]
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| 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
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392742
Contacts
| Contact: Reference Study ID Number: ML25670 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| Bulgaria | |
| Recruiting | |
| Pleven, Bulgaria, 5800 | |
| Recruiting | |
| Plovdiv, Bulgaria, 4002 | |
| Recruiting | |
| Sofia, Bulgaria, 1527 | |
| Recruiting | |
| Sofia, Bulgaria, 1606 | |
| Recruiting | |
| Sofia, Bulgaria, 1407 | |
| Recruiting | |
| Sofia, Bulgaria, 1431 | |
| Recruiting | |
| Sofia, Bulgaria, 1612 | |
| Recruiting | |
| Stara Zagora, Bulgaria, 6000 | |
| Recruiting | |
| Varna, Bulgaria, 9010 | |
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: | NCT01392742 History of Changes |
| Other Study ID Numbers: | ML25670 |
| Study First Received: | July 11, 2011 |
| Last Updated: | June 11, 2013 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency |
Additional relevant MeSH terms:
|
Hepatitis 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 Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013