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

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT01884402
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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 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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-03
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pegasys, injection subcutaneous	Peginterferon alfa-2a	HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin
Pegasys, injection subcutaneous	Ribavirin	HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin

Primary Outcome Measures

Name	Time	Method
Sustained Viral Response (RVS)	1 ½ years (72 weeks)	Measurement of HCV RNA negativization 24 weeks after treatment

Trial Locations

Locations (1)

Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI); 🇪🇸 Sevilla, Spain