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

Hepatitis C, Chronic Clinical Trial

— OPTIM  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884402
• Other study ID #: FPS-PEG-2010-01
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: September 3, 2014
• Start date: October 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

Primary objective:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Peginterferon alfa-2a
Treatment as usual clinical practice
• Ribavirin
Treatment as usual clinical practice

Locations

Country	Name	City	State
Spain	Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Viral Response (RVS)	Measurement of HCV RNA negativization 24 weeks after treatment	1 ½ years (72 weeks)	No