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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Sofía
      • 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 Ramón 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 Sofía
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza Progreso y Salud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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