Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01033045
First received: December 15, 2009
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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


Condition
Hepatitis C

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure

Resource links provided by NLM:


Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • Describe the management of patients with chronic hepatitis C and previous treatment failure [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • To determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19. [ Time Frame: 6 ] [ Designated as safety issue: No ]
    The rs12979860 polymorphism in the gene IL 28B that is located on chromosome 19 showed to be strongly associated with the development of sustained viral response (SVR) in patients with chronic hepatitis C treated with PEG-IFN-α/RBV. Patients with this polymorphism clear the virus more easily.

  • Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments. [ Time Frame: 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2196
Study Start Date: September 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033045

  Hide Study Locations
Locations
Spain
H. de Antequera
Antequera, Andalucía, Spain
H. Puerta de Mar
Cádiz, Andalucía, Spain
H. Puerto Real
Cádiz, Andalucía, Spain
H. Vírgen de las Nieves
Granada, Andalucía, Spain
H. Infanta Elena
Huelva, Andalucía, Spain
H. de Jaen
Jaen, Andalucía, Spain
H. de Jerez
Jerez de la Frontera, Andalucía, Spain
H. Vírgen de la Victoria
Málaga, Andalucía, Spain
H. Carlos Haya
Málaga, Andalucía, Spain
H. de Valme
Sevilla, Andalucía, Spain
H. San Jorge
Huesca, Aragón, Spain
H. Miquel Servet
Zaragoza, Aragón, Spain
H. Clínico de Zaragoza
Zaragoza, Aragón, Spain
H. Central de Astúrias
Oviedo, Astúrias, Spain
H. Carlos III
Madrid, C de Madrid, Spain
H. de Henares
Alcalá de Henares, C. de Madrid, Spain
Fundación de Alcorcón
Alcorcón, C. de Madrid, Spain
H. de Getafe
Getafe, C. de Madrid, Spain
H. la Princesa
Madrid, C. de Madrid, Spain
H. Fundación Jiménez Díaz
Madrid, C. de Madrid, Spain
H. la Paz
Madrid, C. de Madrid, Spain
H. Severo Ochoa
Madrid, C. de Madrid, Spain
H. 12 de Octubre
Madrid, C. de Madrid, Spain
H. Príncipe de Astúrias
Madrid, C. de Madrid, Spain
H. de Móstoles
Móstoles, C. de Madrid, Spain
H. Infanta Cristina
Parla, C. de Madrid, Spain
H. Infanta Sofía
San Sebastian de los Reyes, C. de Madrid, Spain
H. de Alcoy
Alcoy, C. Valenciana, Spain
H. Marina Baixa
Alicante, C. Valenciana, Spain
H. General de Alicante
Alicante, C. Valenciana, Spain
H. de Castellón
Castellón, C. Valenciana, Spain
H. de Elche
Elche, C. Valenciana, Spain
H. Vega Baja
Orihuela, C. Valenciana, Spain
H. General de Valencia
Valencia, C. Valenciana, Spain
H. Clínico de Valencia
Valencia, C. Valenciana, Spain
H. de Xàtiva
Xàtiva, C. Valenciana, Spain
H. Insular
Gran Canaria, Canarias, Spain
H. Dr. José Molina Orrosos
Lanzarote, Canarias, Spain
H. Universitario de Tenerife
Tenerife, Canarias, Spain
H. Candelaria
Tenerife, Canarias, Spain
H. Dr. Negrín
Tenerife, Canarias, Spain
H. de Valdecilla
Santander, Cantabria, Spain
H. de Albacete
Albacete, Castilla la Mancha, Spain
H. Ciudad Real
Ciudad Real, Castilla la Mancha, Spain
H. de Cuenca
Cuenca, Castilla la Mancha, Spain
H. de Manzanares
Manzanares, Castilla la Mancha, Spain
H. Vírgen de la Salud
Toledo, Castilla la Mancha, Spain
H. Alcázar
Toledo, Castilla la Mancha, Spain
H, de Tomelloso
Tomelloso, Castilla la Mancha, Spain
H. de Valdepeñas
Valdepeñas, Castilla la Mancha, Spain
H. de León
León, Castilla y León, Spain
H. Comarcal el Bierzo
Ponferrada, Castilla y León, Spain
H. Clínico de Salamanca
Salamanca, Castilla y León, Spain
H. Clinico de Valladolid
Valladolid, Castilla y León, Spain
H. Río Ortega
Valladolid, Castilla y León, Spain
H. Germans Trias Pujol
Badalona, Cataluña, Spain
Hospital de Bellvitge
Barcelona, Cataluña, Spain
H. Sant Boi
Barcelona, Cataluña, Spain
H. Clínic
Barcelona, Cataluña, Spain
H. Sant Pau
Barcelona, Cataluña, Spain
Xarxa Sanitaria i Social de Santa Tecla (Tarragona)
El Vendrell, Cataluña, Spain
H. de Figueres
Figueres, Cataluña, Spain
H. Josep Trueta
Girona, Cataluña, Spain
H. Santa Caterina
Girona, Cataluña, Spain
H. General de Igualada
Igualada, Cataluña, Spain
H. Sant Joan de Déu de Manresa
Manresa, Cataluña, Spain
H. Sant Joan de Déu de Martorell
Martorell, Cataluña, Spain
H. Sant Joan de Reus
Reus, Cataluña, Spain
H. Parc Taulí de Sabadell
Sabadell, Cataluña, Spain
H. Esperit Sant
Santa Coloma de Gramanet, Cataluña, Spain
H. Joan XXIII
Tarragona, Cataluña, Spain
H. Verge de la Cinta de Tortosa
Tortosa, Cataluña, Spain
H. General de Vic
Vic, Cataluña, Spain
H. de Viladecans
Viladecans, Cataluña, Spain
H. Infanta Cristina
Badajoz, Extremadura, Spain
H. de Coria/Plasencia
Coria, Extremadura, Spain
H. San Pedro Alcántara
Cáceres, Extremadura, Spain
H. de Mérida
Mérida, Extremadura, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain
H. Arquitecto Marcide
Ferrol, Galicia, Spain
Complexo Hospitalario Ourense
Ourense, Galicia, Spain
Complexo Hospitalario Pontevedra
Pontevedra, Galicia, Spain
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, Galicia, Spain
H. Xeral Cíes
Vigo, Galicia, Spain
H. Meixoeiro
Vigo, Galicia, Spain
Complejo hospitalario Vigo
Vigo, Galicia, Spain
POVISA
Vigo, Galicia, Spain
H. Son Dureta
Mallorca, Illes Balears, Spain
H. Son Llàtzer
Mallorca, Illes Balears, Spain
H. Manacor
Manacor, Illes Balears, Spain
H. Santa Mª del Rosell
Cartagena, Múrcia, Spain
H. de Arritxaca
El Palmar, Múrcia, Spain
H. de Lorca
Lorca, Múrcia, Spain
H. de Navarra
Pamplona, Navarra, Spain
H. las Cruces
Bilbao, País Vasco, Spain
H. de Galdakano
Bilbao, País Vasco, Spain
H. Basurto
Bilbao, País Vasco, Spain
H. de Donosti
San Sebastián, País Vasco, Spain
Hospital del Mar
Barcelona, Spain
H. Puerta del Hierro
Madrid, Spain
H. Morales Messeguer
Múrcia, Spain
H. General de Múrcia
Múrcia, Spain
H. Vírgen del Rocío
Sevilla, Spain
Sponsors and Collaborators
Fundacion IMIM
Investigators
Principal Investigator: Ricard Solà Lamoglia, Dr. Hospital del Mar, Barcelona
Principal Investigator: Ramón Planas Vila, Dr. Hospital Germans Tries i Pujol, Barcelona
Principal Investigator: Javier García-Samaniego, Dr. Hospital Carlos III, Madrid
Principal Investigator: Moisés Diago, Dr. Hospital General de Valencia
Principal Investigator: Manuel Romero, Dr. Hospital de Valme, Sevilla
Principal Investigator: José Luís Calleja, Dr Hospital Puerta del Hierro, Madrid
  More Information

No publications provided

Responsible Party: Fundacion IMIM
ClinicalTrials.gov Identifier: NCT01033045     History of Changes
Other Study ID Numbers: AGORA
Study First Received: December 15, 2009
Last Updated: October 14, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion IMIM:
Hepatitis C
Viral
Non-A
Non-B
Parenterally-Transmitted

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014