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OpenTrials
Completed

NCT Number: NCT01884402

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

Primary objective:

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

Completed

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peginterferon alfa-2a

Drug

Treatment as usual clinical practice

Other names: Pegasys

Ribavirin

Drug

Treatment as usual clinical practice

Other names: Copegus

Primary outcomes

  1. Sustained Viral Response (RVS)

    Time frame: 1 ½ years (72 weeks)

    Measurement of HCV RNA negativization 24 weeks after treatment

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study 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.

Acronym: OPTIM

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2013
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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