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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla770 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

770

Conditions

Hepatitis C, Chronic

Interventions

Peginterferon alfa-2aDRUG

Treatment as usual clinical practice

RibavirinDRUG

Treatment as usual clinical practice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with \> 18 years old. * Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions. * Patients Genotype 1 and 4. * Patients with the results of all the factors evaluable at the time of inclusion. * Patients who have accepted their participation in the study through informed consent. Exclusion Criteria: * Patients previously treated with interferon (IFN) and ribavirin (RBV). * Patients with genotype 2, 3, 5 and 6. * Patients with co-infection with hepatitis B. * Patients with other liver diseases. * Patients with any contraindications to the drugs used in the treatment of hepatitis C.

Locations (2)

Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)

Seville, Sevilla, Spain

Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)

Seville, Spain

Outcomes

Primary Outcomes

Sustained Viral Response (RVS)

Measurement of HCV RNA negativization 24 weeks after treatment

Time frame: 1 ½ years (72 weeks)

Data from ClinicalTrials.gov

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