Clinical trial NCT01033045: Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure
Official title: Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C
Viral
Non-A
Non-B
Parenterally-Transmitted
Lead sponsor: Fundacion IMIM
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 2178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sexes older than 18 years old with hepatitis C who had previously failed to the standard therapy.

Brief summary: The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes older than 18 years old.
* Patients with hepatitis C who had previously failed to the standard therapy.
* Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

* Patients with clinical and/or social conditions that might interfere with the development of the study (terminal diseases, cognitive detriment, severe psychiatric disease which prevent from obtaining the information required, prolonged absences during the study).
* Patients who are participating in other research trials or under treatment with any agent contraindicated according to the summary of product characteristics or other circumstance which requires a patient management different from the investigator's regular clinical practice.

Primary outcomes:
measure: Describe the management of patients with chronic hepatitis C and previous treatment failure
timeFrame: 6 years
Secondary outcomes:
measure: To know the frequency of the causes for not responding to the previous treatment: lack of adherence to treatment, incomplete dose of antiviral treatment, insufficient treatment duration or treatment resistance.
timeFrame: 6 years
measure: To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes.
timeFrame: 6 years
measure: To evaluate the implementation of current recommendations based on the cause of the previous therapeutic failure, in patients with chronic hepatitis C in whom a new course of the antiviral treatment is decided to be administered.
timeFrame: 6 years
measure: To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment.
timeFrame: 6 years
measure: To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure.
timeFrame: 6 years
measure: To determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19.
timeFrame: 6
measure: Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments.
timeFrame: 3
Other outcomes:
Locations:
city: Antequera
country: Spain
facility: H. de Antequera
state: Andalucía
city: Cádiz
country: Spain
facility: H. Puerta de Mar
state: Andalucía
city: Cádiz
country: Spain
facility: H. Puerto Real
state: Andalucía
city: Granada
country: Spain
facility: H. Vírgen de las Nieves
state: Andalucía
city: Huelva
country: Spain
facility: H. Infanta Elena
state: Andalucía
city: Jaen
country: Spain
facility: H. de Jaen
state: Andalucía
city: Jerez de la Frontera
country: Spain
facility: H. de Jerez
state: Andalucía
city: Málaga
country: Spain
facility: H. Carlos Haya
state: Andalucía
city: Málaga
country: Spain
facility: H. Vírgen de la Victoria
state: Andalucía
city: Sevilla
country: Spain
facility: H. de Valme
state: Andalucía
city: Huesca
country: Spain
facility: H. San Jorge
state: Aragón
city: Zaragoza
country: Spain
facility: H. Clínico de Zaragoza
state: Aragón
city: Zaragoza
country: Spain
facility: H. Miquel Servet
state: Aragón
city: Oviedo
country: Spain
facility: H. Central de Astúrias
state: Astúrias
city: Madrid
country: Spain
facility: H. Carlos III
state: C de Madrid
city: Alcalá de Henares
country: Spain
facility: H. de Henares
state: C. de Madrid
city: Alcorcón
country: Spain
facility: Fundación de Alcorcón
state: C. de Madrid
city: Getafe
country: Spain
facility: H. de Getafe
state: C. de Madrid
city: Madrid
country: Spain
facility: H. 12 de Octubre
state: C. de Madrid
city: Madrid
country: Spain
facility: H. Fundación Jiménez Díaz
state: C. de Madrid
city: Madrid
country: Spain
facility: H. la Paz
state: C. de Madrid
city: Madrid
country: Spain
facility: H. la Princesa
state: C. de Madrid
city: Madrid
country: Spain
facility: H. Príncipe de Astúrias
state: C. de Madrid
city: Madrid
country: Spain
facility: H. Severo Ochoa
state: C. de Madrid
city: Móstoles
country: Spain
facility: H. de Móstoles
state: C. de Madrid
city: Parla
country: Spain
facility: H. Infanta Cristina
state: C. de Madrid
city: San Sebastian de los Reyes
country: Spain
facility: H. Infanta Sofía
state: C. de Madrid
city: Alcoy
country: Spain
facility: H. de Alcoy
state: C. Valenciana
city: Alicante
country: Spain
facility: H. General de Alicante
state: C. Valenciana
city: Alicante
country: Spain
facility: H. Marina Baixa
state: C. Valenciana
city: Castellón
country: Spain
facility: H. de Castellón
state: C. Valenciana
city: Elche
country: Spain
facility: H. de Elche
state: C. Valenciana
city: Orihuela
country: Spain
facility: H. Vega Baja
state: C. Valenciana
city: Valencia
country: Spain
facility: H. Clínico de Valencia
state: C. Valenciana
city: Valencia
country: Spain
facility: H. General de Valencia
state: C. Valenciana
city: Xàtiva
country: Spain
facility: H. de Xàtiva
state: C. Valenciana
city: Gran Canaria
country: Spain
facility: H. Insular
state: Canarias
city: Lanzarote
country: Spain
facility: H. Dr. José Molina Orrosos
state: Canarias
city: Tenerife
country: Spain
facility: H. Candelaria
state: Canarias
city: Tenerife
country: Spain
facility: H. Dr. Negrín
state: Canarias
city: Tenerife
country: Spain
facility: H. Universitario de Tenerife
state: Canarias
city: Santander
country: Spain
facility: H. de Valdecilla
state: Cantabria
city: Albacete
country: Spain
facility: H. de Albacete
state: Castilla la Mancha
city: Ciudad Real
country: Spain
facility: H. Ciudad Real
state: Castilla la Mancha
city: Cuenca
country: Spain
facility: H. de Cuenca
state: Castilla la Mancha
city: Manzanares
country: Spain
facility: H. de Manzanares
state: Castilla la Mancha
city: Toledo
country: Spain
facility: H. Alcázar
state: Castilla la Mancha
city: Toledo
country: Spain
facility: H. Vírgen de la Salud
state: Castilla la Mancha
city: Tomelloso
country: Spain
facility: H, de Tomelloso
state: Castilla la Mancha
city: Valdepeñas
country: Spain
facility: H. de Valdepeñas
state: Castilla la Mancha
city: León
country: Spain
facility: H. de León
state: Castilla y León
city: Ponferrada
country: Spain
facility: H. Comarcal el Bierzo
state: Castilla y León
city: Salamanca
country: Spain
facility: H. Clínico de Salamanca
state: Castilla y León
city: Valladolid
country: Spain
facility: H. Clinico de Valladolid
state: Castilla y León
city: Valladolid
country: Spain
facility: H. Río Ortega
state: Castilla y León
city: Badalona
country: Spain
facility: H. Germans Trias Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: H. Clínic
state: Cataluña
city: Barcelona
country: Spain
facility: H. Sant Boi
state: Cataluña
city: Barcelona
country: Spain
facility: H. Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
state: Cataluña
city: El Vendrell
country: Spain
facility: Xarxa Sanitaria i Social de Santa Tecla (Tarragona)
state: Cataluña
city: Figueres
country: Spain
facility: H. de Figueres
state: Cataluña
city: Girona
country: Spain
facility: H. Josep Trueta
state: Cataluña
city: Girona
country: Spain
facility: H. Santa Caterina
state: Cataluña
city: Igualada
country: Spain
facility: H. General de Igualada
state: Cataluña
city: Manresa
country: Spain
facility: H. Sant Joan de Déu de Manresa
state: Cataluña
city: Martorell
country: Spain
facility: H. Sant Joan de Déu de Martorell
state: Cataluña
city: Reus
country: Spain
facility: H. Sant Joan de Reus
state: Cataluña
city: Sabadell
country: Spain
facility: H. Parc Taulí de Sabadell
state: Cataluña
city: Santa Coloma de Gramanet
country: Spain
facility: H. Esperit Sant
state: Cataluña
city: Tarragona
country: Spain
facility: H. Joan XXIII
state: Cataluña
city: Tortosa
country: Spain
facility: H. Verge de la Cinta de Tortosa
state: Cataluña
city: Vic
country: Spain
facility: H. General de Vic
state: Cataluña
city: Viladecans
country: Spain
facility: H. de Viladecans
state: Cataluña
city: Badajoz
country: Spain
facility: H. Infanta Cristina
state: Extremadura
city: Coria
country: Spain
facility: H. de Coria/Plasencia
state: Extremadura
city: Cáceres
country: Spain
facility: H. San Pedro Alcántara
state: Extremadura
city: Mérida
country: Spain
facility: H. de Mérida
state: Extremadura
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: Galicia
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
state: Galicia
city: Ferrol
country: Spain
facility: H. Arquitecto Marcide
state: Galicia
city: Ourense
country: Spain
facility: Complexo Hospitalario Ourense
state: Galicia
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Pontevedra
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
state: Galicia
city: Vigo
country: Spain
facility: Complejo hospitalario Vigo
state: Galicia
city: Vigo
country: Spain
facility: H. Meixoeiro
state: Galicia
city: Vigo
country: Spain
facility: H. Xeral Cíes
state: Galicia
city: Vigo
country: Spain
facility: POVISA
state: Galicia
city: Mallorca
country: Spain
facility: H. Son Dureta
state: Illes Balears
city: Mallorca
country: Spain
facility: H. Son Llàtzer
state: Illes Balears
city: Manacor
country: Spain
facility: H. Manacor
state: Illes Balears
city: Cartagena
country: Spain
facility: H. Santa Mª del Rosell
state: Múrcia
city: El Palmar
country: Spain
facility: H. de Arritxaca
state: Múrcia
city: Lorca
country: Spain
facility: H. de Lorca
state: Múrcia
city: Pamplona
country: Spain
facility: H. de Navarra
state: Navarra
city: Bilbao
country: Spain
facility: H. Basurto
state: País Vasco
city: Bilbao
country: Spain
facility: H. de Galdakano
state: País Vasco
city: Bilbao
country: Spain
facility: H. las Cruces
state: País Vasco
city: San Sebastián
country: Spain
facility: H. de Donosti
state: País Vasco
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: H. Puerta del Hierro
city: Múrcia
country: Spain
facility: H. General de Múrcia
city: Múrcia
country: Spain
facility: H. Morales Messeguer
city: Sevilla
country: Spain
facility: H. Vírgen del Rocío
Study officials:
affiliation: Hospital del Mar
name: Ricard Solà Lamoglia, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Germans Tries i Pujol, Barcelona
name: Ramón Planas Vila, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Carlos III, Madrid
name: Javier García-Samaniego, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Valencia
name: Moisés Diago, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Valme, Sevilla
name: Manuel Romero, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta del Hierro, Madrid
name: José Luís Calleja, Dr
role: PRINCIPAL_INVESTIGATOR
References: