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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: Peginterferon alfa-2a

Study type: Observational

Funder types: Other

Identifiers

NCT01884402

FPS-PEG-2010-01

Details and patient eligibility

About

Primary objective:

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

Full description

This Tool:

Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR). Identify those patients most likely to respond. 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.

Enrollment: 770 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

770 participants in 1 patient group

Pegasys, injection subcutaneous

Description:

HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin

Treatment:

Drug: Peginterferon alfa-2a

Drug: Ribavirin