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 May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01392742

First received: July 11, 2011

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2011

Last Updated Date

May 7, 2013

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01392742 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with chronic hepatitis C treated with Pegasys and ribavirin

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Cohort

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

September 2015

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: ML25670 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

Bulgaria

Administrative Information

NCT Number ^ICMJE

NCT01392742

Other Study ID Numbers ^ICMJE

ML25670

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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