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

NCT01033045 | Completed DMC

• 1 other identifier: AGORA
• Study Type: observational
• Target: 2,178
• Locations: 1 country
• Sites: 104

Brief Summary

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

Conditions

Hepatitis C

Keywords

Hepatitis C; Viral; Non-A; Non-B; Parenterally-Transmitted

Outcome Measures

Primary Outcomes (1)

• Describe the management of patients with chronic hepatitis C and previous treatment failure

  6 years

Secondary Outcomes (7)

• 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.

  6 years

• To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes.

  6 years

• 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.

  6 years

• To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment.

  6 years

• To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure.

  6 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion IMIM: lead

Study Sites (104)

H. de Antequera

Antequera, Andalusia, Spain

Location

H. Puerta de Mar

Cadiz, Andalusia, Spain

Location

H. Puerto Real

Cadiz, Andalusia, Spain

Location

H. Vírgen de las Nieves

Granada, Andalusia, Spain

Location

H. Infanta Elena

Huelva, Andalusia, Spain

Location

H. de Jaen

Jaén, Andalusia, Spain

Location

H. de Jerez

Jerez de la Frontera, Andalusia, Spain

Location

H. Carlos Haya

Málaga, Andalusia, Spain

Location

H. Vírgen de la Victoria

Málaga, Andalusia, Spain

Location

H. de Valme

Seville, Andalusia, Spain

Location

H. San Jorge

Huesca, Aragon, Spain

Location

H. Clínico de Zaragoza

Zaragoza, Aragon, Spain

Location

H. Miquel Servet

Zaragoza, Aragon, Spain

Location

H. Son Dureta

Mallorca, Balearic Islands, Spain

Location

H. Son Llàtzer

Mallorca, Balearic Islands, Spain

Location

H. Manacor

Manacor, Balearic Islands, Spain

Location

Hospital del Mar

Barcelona, Barcelona, Spain

Location

H. Basurto

Bilbao, Basque Country, Spain

Location

H. de Galdakano

Bilbao, Basque Country, Spain

Location

H. las Cruces

Bilbao, Basque Country, Spain

Location

H. de Donosti

Donostia / San Sebastian, Basque Country, Spain

Location

H. Carlos III

Madrid, C de Madrid, Spain

Location

H. de Henares

Alcalá de Henares, C. de Madrid, Spain

Location

Fundación de Alcorcón

Alcorcón, C. de Madrid, Spain

Location

H. de Getafe

Getafe, C. de Madrid, Spain

Location

H. 12 de Octubre

Madrid, C. de Madrid, Spain

Location

H. Fundación Jiménez Díaz

Madrid, C. de Madrid, Spain

Location

H. la Paz

Madrid, C. de Madrid, Spain

Location

H. la Princesa

Madrid, C. de Madrid, Spain

Location

H. Príncipe de Astúrias

Madrid, C. de Madrid, Spain

Location

H. Severo Ochoa

Madrid, C. de Madrid, Spain

Location

H. de Móstoles

Móstoles, C. de Madrid, Spain

Location

H. Infanta Cristina

Parla, C. de Madrid, Spain

Location

H. Infanta Sofía

San Sebastián de los Reyes, C. de Madrid, Spain

Location

H. de Alcoy

Alcoy, C. Valenciana, Spain

Location

H. General de Alicante

Alicante, C. Valenciana, Spain

Location

H. Marina Baixa

Alicante, C. Valenciana, Spain

Location

H. de Castellón

Castellon, C. Valenciana, Spain

Location

H. de Elche

Elche, C. Valenciana, Spain

Location

H. Vega Baja

Orihuela, C. Valenciana, Spain

Location

H. Clínico de Valencia

Valencia, C. Valenciana, Spain

Location

H. General de Valencia

Valencia, C. Valenciana, Spain

Location

H. de Xàtiva

Xàtiva, C. Valenciana, Spain

Location

H. Insular

Gran Canaria, Canary Islands, Spain

Location

H. Dr. José Molina Orrosos

Lanzarote, Canary Islands, Spain

Location

H. Candelaria

Santa Cruz de Tenerife, Canary Islands, Spain

Location

H. Dr. Negrín

Santa Cruz de Tenerife, Canary Islands, Spain

Location

H. Universitario de Tenerife

Santa Cruz de Tenerife, Canary Islands, Spain

Location

H. de Valdecilla

Santander, Cantabria, Spain

Location

H. de León

León, Castille and León, Spain

Location

H. Comarcal el Bierzo

Ponferrada, Castille and León, Spain

Location

H. Clínico de Salamanca

Salamanca, Castille and León, Spain

Location

H. Clinico de Valladolid

Valladolid, Castille and León, Spain

Location

H. Río Ortega

Valladolid, Castille and León, Spain

Location

H. de Albacete

Albacete, Castille-La Mancha, Spain

Location

H. Ciudad Real

Ciudad Real, Castille-La Mancha, Spain

Location

H. de Cuenca

Cuenca, Castille-La Mancha, Spain

Location

H. de Manzanares

Manzanares, Castille-La Mancha, Spain

Location

H. Alcázar

Toledo, Castille-La Mancha, Spain

Location

H. Vírgen de la Salud

Toledo, Castille-La Mancha, Spain

Location

H, de Tomelloso

Tomelloso, Castille-La Mancha, Spain

Location

H. de Valdepeñas

Valdepeñas, Castille-La Mancha, Spain

Location

H. Germans Trias Pujol

Badalona, Catalonia, Spain

Location

H. Clínic

Barcelona, Catalonia, Spain

Location

H. Sant Boi

Barcelona, Catalonia, Spain

Location

H. Sant Pau

Barcelona, Catalonia, Spain

Location

Hospital de Bellvitge

Barcelona, Catalonia, Spain

Location

Xarxa Sanitaria i Social de Santa Tecla (Tarragona)

El Vendrell, Catalonia, Spain

Location

H. de Figueres

Figueres, Catalonia, Spain

Location

H. Josep Trueta

Girona, Catalonia, Spain

Location

H. Santa Caterina

Girona, Catalonia, Spain

Location

H. General de Igualada

Igualada, Catalonia, Spain

Location

H. Sant Joan de Déu de Manresa

Manresa, Catalonia, Spain

Location

H. Sant Joan de Déu de Martorell

Martorell, Catalonia, Spain

Location

H. Sant Joan de Reus

Reus, Catalonia, Spain

Location

H. Parc Taulí de Sabadell

Sabadell, Catalonia, Spain

Location

H. Esperit Sant

Santa Coloma de Gramanet, Catalonia, Spain

Location

H. Joan XXIII

Tarragona, Catalonia, Spain

Location

H. Verge de la Cinta de Tortosa

Tortosa, Catalonia, Spain

Location

H. General de Vic

Vic, Catalonia, Spain

Location

H. de Viladecans

Viladecans, Catalonia, Spain

Location

H. Infanta Cristina

Badajoz, Extremadura, Spain

Location

H. San Pedro Alcántara

Cáceres, Extremadura, Spain

Location

H. de Coria/Plasencia

Coria, Extremadura, Spain

Location

H. de Mérida

Mérida, Extremadura, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Location

H. Arquitecto Marcide

Ferrol, Galicia, Spain

Location

Complexo Hospitalario Ourense

Ourense, Galicia, Spain

Location

Complexo Hospitalario Pontevedra

Pontevedra, Galicia, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Galicia, Spain

Location

Complejo hospitalario Vigo

Vigo, Galicia, Spain

Location

H. Meixoeiro

Vigo, Galicia, Spain

Location

H. Xeral Cíes

Vigo, Galicia, Spain

Location

POVISA

Vigo, Galicia, Spain

Location

H. Puerta del Hierro

Madrid, Madrid, Spain

Location

H. Santa Mª del Rosell

Cartagena, Murcia, Spain

Location

H. de Arritxaca

El Palmar, Murcia, Spain

Location

H. de Lorca

Lorca, Murcia, Spain

Location

H. General de Múrcia

Murcia, Murcia, Spain

Location

H. Morales Messeguer

Murcia, Murcia, Spain

Location

H. de Navarra

Pamplona, Navarre, Spain

Location

H. Central de Astúrias

Oviedo, Principality of Asturias, Spain

Location

H. Vírgen del Rocío

Seville, Sevilla, Spain

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Ricard Solà Lamoglia, Dr.

  Hospital del Mar

  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 Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Manuel Romero, Dr.

  Hospital de Valme, Sevilla

  PRINCIPAL INVESTIGATOR

• José Luís Calleja, Dr

  Hospital Puerta del Hierro, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

ES (104)