Register of Telaprevir and Boceprevir in Routine Clinical Practice

July 14, 2015 updated by: Fundación Pública Andaluza Progreso y Salud
Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1553

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain
        • Hospital de Poniente
      • Almería, Spain
        • Hospital Torrecardenas
      • Badajoz, Spain
        • Hospital Infanta Cristina
      • Bilbao, Spain
        • Hospital Universitario de Cruces
      • Ciudad Real, Spain
        • Hospital General de Ciudad Real
      • Cáceres, Spain
        • Hospital San Pedro de Alcantara
      • Cádiz, Spain
        • Hospital Puerta del Mar
      • Córdoba, Spain
        • Hospital Reina Sofia
      • Granada, Spain
        • Hospital Universitario de San Cecilio
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
      • Guadalajara, Spain
        • Hospital de Guadalajara
      • Huelva, Spain
        • Hospital Juan Ramón Jimenez
      • Huesca, Spain
        • Hospital San Jorge
      • Jaén, Spain
        • Complejo Hospitalario de Jaen
      • La Coruña, Spain
        • Hospital Universitario A Coruña
      • León, Spain
        • Hospital de Leon
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario De La Princesa
      • Murcia, Spain
        • Hospital Universitario Virgen de La Arrixaca
      • Murcia, Spain
        • Hospital Morales Meseguer
      • Murcia, Spain
        • Hospital Reina Sofia
      • Málaga, Spain
        • Hospital Universitario Carlos Haya
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • San Sebastián, Spain
        • Hospital Universitario de Donostia
      • Sevilla, Spain
        • Hospital Universitario de Valme
      • Sevilla, Spain
        • Hospital Universitario Virgen De La Macarena
      • Sevilla, Spain
        • Hospital Unviersitario Virgen del Rocio
      • Toledo, Spain
        • Complejo Hospitalario de Toledo
      • Valencia, Spain
        • Hospital Arnau De Vilanova
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Valencia, Spain
        • Hospital General de Valencia
      • Valencia, Spain
        • Hospital La Fe
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid
      • Valladolid, Spain
        • Hospital Universitario Rio Hortega
      • Zamora, Spain
        • Hospital de Zamora
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
      • Zaragoza, Spain
        • Hospital Clínico Universitario de Zaragoza
    • Gran Canaria
      • Las Palmas de Gran Canaria, Gran Canaria, Spain
        • Hospital Universitario Doctor Negrín
    • Granada
      • Motril, Granada, Spain
        • Hospital Comarcal Santa Ana
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
        • Hospital Universitario de Santiago de Compostela
    • Madrid
      • Alcorcón, Madrid, Spain
        • Hospital Universitario Fundacion Alcorcon
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain
        • Hospital Son Espases
    • Murcia
      • Lorca, Murcia, Spain
        • Hospital General Universitario Rafael Méndez
    • Málaga
      • Marbella, Málaga, Spain
        • Agencia Sanitaria Costa del Sol
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spain
        • Hospital Universitario Nuestra Señora de la Candelaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hepatitis C, genotype 1, who are elegible to be treated with telaprevir or boceprevir

Description

Inclusion Criteria:

  • Patients infected by hepatitis C virus, genotype 1
  • Indication of treatment with telaprevir or boceprevir in F3 and F4 fibrosis

Exclusion Criteria:

  • Being taking part in other
  • Inability to follow a monitoring
  • Contra-indications on triple therapy
  • Coinfected with HIV and HBV (hepatitis B virus)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Patients with hepatitis C, genotype 1
Patients with hepatitis C, genotype 1, treated with telaprevir or boceprevir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Time Frame: 12 months
Know through routine clinical practice the percentage of patients who have negative VHC-ARN
12 months
Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Time Frame: 12 months
Number and frequencies of serious adverse event (SAE) during the treatment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Investigators

  • Principal Investigator: Javier Salmerón Escobar, Hospital Universitario de San Cecilio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPS-TEL-2013-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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