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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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