Status:

COMPLETED

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

Lead Sponsor:

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Conditions:

Hepatitis C, Chronic

Eligibility:

All Genders

18-65 years

Brief 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 li...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2014

Estimated Enrollment :

770 Patients enrolled

Trial Details

Trial ID

NCT01884402

Start Date

October 1 2010

End Date

August 1 2014

Last Update

September 4 2014

Active Locations (2)

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Page 1 of 1 (2 locations)

1

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

Seville, Sevilla, Spain

2

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

Seville, Spain