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

Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected With Chronic Hepatitis C Receiving a Long Acting Interferon Plus Ribavirin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01344889

Enrollment

4459

Registered

2011-04-29

Start date

2009-10-31

Completion date

2013-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Correlation of on-treatment factors and dose reduction/treatment discontinuation	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
Safety: Incidence of adverse events	4 years

Countries

Albania, Algeria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Egypt, Greece, Hungary, India, Iran, Italy, Kuwait, Lebanon, Morocco, North Macedonia, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Slovakia, South Korea, United Arab Emirates

Outcome results