An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT01344889
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-29
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4459

Inclusion Criteria

• Adult patients (according to local legislation)
• Chronic hepatitis C
• Treatment with long-acting interferon plus ribavirin
• Quantifiable HCV RNA before initiation of treatment
• No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label

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Exclusion Criteria

• End stage renal disease
• Major organ transplantation
• Concomitant therapy with telbivudine
• Pregnant or breast-feeding females
• Male partners of pregnant females

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin	4 years
Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment)	4 years

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	4 years
Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR	4 years
Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients	4 years
Correlation of on-treatment factors and dose reduction/treatment discontinuation	4 years