NCT01884402

Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4

Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 770 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.

Detailed description

This Tool: 1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR). 2. Identify those patients most likely to respond. 3. Therapy and therefore optimize resources The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a	Treatment as usual clinical practice
DRUG	Ribavirin	Treatment as usual clinical practice

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2013-06-24
• Last updated: 2014-09-04

Locations

2 sites across 1 country: Spain