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

Completed

• Conditions: Hepatitis C

• Registration Number: NCT01033045
• Lead Sponsor: Fundacion IMIM

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2178

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the management of patients with chronic hepatitis C and previous treatment failure	6 years

Secondary Outcome Measures

Name	Time	Method
To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes.	6 years
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 determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19.	6	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.
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
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
Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments.	3
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

Trial Locations

Locations (103)

H. Marina Baixa; 🇪🇸 Alicante, C. Valenciana, Spain

H. Infanta Sofía; 🇪🇸 San Sebastian de los Reyes, C. de Madrid, Spain

H. Fundación Jiménez Díaz; 🇪🇸 Madrid, C. de Madrid, Spain

H. de Antequera; 🇪🇸 Antequera, Andalucía, Spain

H. de Valme; 🇪🇸 Sevilla, Andalucía, Spain

H. San Jorge; 🇪🇸 Huesca, Aragón, Spain

H. Infanta Elena; 🇪🇸 Huelva, Andalucía, Spain

H. Vírgen de las Nieves; 🇪🇸 Granada, Andalucía, Spain

H. de Jerez; 🇪🇸 Jerez de la Frontera, Andalucía, Spain

H. la Princesa; 🇪🇸 Madrid, C. de Madrid, Spain

H. de Móstoles; 🇪🇸 Móstoles, C. de Madrid, Spain

H. Vírgen de la Victoria; 🇪🇸 Málaga, Andalucía, Spain

H. Dr. Negrín; 🇪🇸 Tenerife, Canarias, Spain

H. Clínic; 🇪🇸 Barcelona, Cataluña, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Galicia, Spain

H. Parc Taulí de Sabadell; 🇪🇸 Sabadell, Cataluña, Spain

H. Candelaria; 🇪🇸 Tenerife, Canarias, Spain

H. Clínico de Zaragoza; 🇪🇸 Zaragoza, Aragón, Spain

H. de Getafe; 🇪🇸 Getafe, C. de Madrid, Spain

H. Carlos III; 🇪🇸 Madrid, C de Madrid, Spain

H. Carlos Haya; 🇪🇸 Málaga, Andalucía, Spain

H. Insular; 🇪🇸 Gran Canaria, Canarias, Spain

H. Central de Astúrias; 🇪🇸 Oviedo, Astúrias, Spain

Fundación de Alcorcón; 🇪🇸 Alcorcón, C. de Madrid, Spain

H. de Jaen; 🇪🇸 Jaen, Andalucía, Spain

H. Ciudad Real; 🇪🇸 Ciudad Real, Castilla la Mancha, Spain

H. General de Alicante; 🇪🇸 Alicante, C. Valenciana, Spain

H. de León; 🇪🇸 León, Castilla y León, Spain

H. Clinico de Valladolid; 🇪🇸 Valladolid, Castilla y León, Spain

H. Vega Baja; 🇪🇸 Orihuela, C. Valenciana, Spain

H. General de Igualada; 🇪🇸 Igualada, Cataluña, Spain

Hospital de Bellvitge; 🇪🇸 Barcelona, Cataluña, Spain

Complejo hospitalario Vigo; 🇪🇸 Vigo, Galicia, Spain

H. Verge de la Cinta de Tortosa; 🇪🇸 Tortosa, Cataluña, Spain

H. de Viladecans; 🇪🇸 Viladecans, Cataluña, Spain

H. Arquitecto Marcide; 🇪🇸 Ferrol, Galicia, Spain

H. Morales Messeguer; 🇪🇸 Múrcia, Spain

H. Puerta del Hierro; 🇪🇸 Madrid, Spain

H. Vírgen del Rocío; 🇪🇸 Sevilla, Spain

H. de Donosti; 🇪🇸 San Sebastián, País Vasco, Spain

H. Manacor; 🇪🇸 Manacor, Illes Balears, Spain

H. Dr. José Molina Orrosos; 🇪🇸 Lanzarote, Canarias, Spain

H. 12 de Octubre; 🇪🇸 Madrid, C. de Madrid, Spain

H. la Paz; 🇪🇸 Madrid, C. de Madrid, Spain

H. de Castellón; 🇪🇸 Castellón, C. Valenciana, Spain

H. de Elche; 🇪🇸 Elche, C. Valenciana, Spain

H. General de Valencia; 🇪🇸 Valencia, C. Valenciana, Spain

Xarxa Sanitaria i Social de Santa Tecla (Tarragona); 🇪🇸 El Vendrell, Cataluña, Spain

H. de Cuenca; 🇪🇸 Cuenca, Castilla la Mancha, Spain

H. Río Ortega; 🇪🇸 Valladolid, Castilla y León, Spain

H. Germans Trias Pujol; 🇪🇸 Badalona, Cataluña, Spain

H. Alcázar; 🇪🇸 Toledo, Castilla la Mancha, Spain

H. Vírgen de la Salud; 🇪🇸 Toledo, Castilla la Mancha, Spain

H. Comarcal el Bierzo; 🇪🇸 Ponferrada, Castilla y León, Spain

H. Sant Boi; 🇪🇸 Barcelona, Cataluña, Spain

H. de Figueres; 🇪🇸 Figueres, Cataluña, Spain

H. Sant Joan de Déu de Martorell; 🇪🇸 Martorell, Cataluña, Spain

H. Josep Trueta; 🇪🇸 Girona, Cataluña, Spain

H. Santa Caterina; 🇪🇸 Girona, Cataluña, Spain

H. Sant Joan de Déu de Manresa; 🇪🇸 Manresa, Cataluña, Spain

H. Joan XXIII; 🇪🇸 Tarragona, Cataluña, Spain

POVISA; 🇪🇸 Vigo, Galicia, Spain

H. Sant Joan de Reus; 🇪🇸 Reus, Cataluña, Spain

H. Santa Mª del Rosell; 🇪🇸 Cartagena, Múrcia, Spain

H. de Lorca; 🇪🇸 Lorca, Múrcia, Spain

H. General de Vic; 🇪🇸 Vic, Cataluña, Spain

H. San Pedro Alcántara; 🇪🇸 Cáceres, Extremadura, Spain

Complexo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Galicia, Spain

H. de Mérida; 🇪🇸 Mérida, Extremadura, Spain

Complexo Hospitalario Ourense; 🇪🇸 Ourense, Galicia, Spain

H. Meixoeiro; 🇪🇸 Vigo, Galicia, Spain

H. Xeral Cíes; 🇪🇸 Vigo, Galicia, Spain

H. Son Dureta; 🇪🇸 Mallorca, Illes Balears, Spain

H. Son Llàtzer; 🇪🇸 Mallorca, Illes Balears, Spain

H. de Arritxaca; 🇪🇸 El Palmar, Múrcia, Spain

H. General de Múrcia; 🇪🇸 Múrcia, Spain

H. Basurto; 🇪🇸 Bilbao, País Vasco, Spain

H. Puerto Real; 🇪🇸 Cádiz, Andalucía, Spain

H. Puerta de Mar; 🇪🇸 Cádiz, Andalucía, Spain

H. Miquel Servet; 🇪🇸 Zaragoza, Aragón, Spain

H. de Henares; 🇪🇸 Alcalá de Henares, C. de Madrid, Spain

H. Infanta Cristina; 🇪🇸 Badajoz, Extremadura, Spain

H. Príncipe de Astúrias; 🇪🇸 Madrid, C. de Madrid, Spain

H. Severo Ochoa; 🇪🇸 Madrid, C. de Madrid, Spain

H. de Alcoy; 🇪🇸 Alcoy, C. Valenciana, Spain

H. Clínico de Valencia; 🇪🇸 Valencia, C. Valenciana, Spain

H. de Xàtiva; 🇪🇸 Xàtiva, C. Valenciana, Spain

H. de Albacete; 🇪🇸 Albacete, Castilla la Mancha, Spain

H. de Manzanares; 🇪🇸 Manzanares, Castilla la Mancha, Spain

H, de Tomelloso; 🇪🇸 Tomelloso, Castilla la Mancha, Spain

H. de Valdepeñas; 🇪🇸 Valdepeñas, Castilla la Mancha, Spain

H. Clínico de Salamanca; 🇪🇸 Salamanca, Castilla y León, Spain

H. Sant Pau; 🇪🇸 Barcelona, Cataluña, Spain

H. Esperit Sant; 🇪🇸 Santa Coloma de Gramanet, Cataluña, Spain

H. de Coria/Plasencia; 🇪🇸 Coria, Extremadura, Spain

Complexo Hospitalario Pontevedra; 🇪🇸 Pontevedra, Galicia, Spain

Complexo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, Galicia, Spain

H. de Galdakano; 🇪🇸 Bilbao, País Vasco, Spain

H. las Cruces; 🇪🇸 Bilbao, País Vasco, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

H. Universitario de Tenerife; 🇪🇸 Tenerife, Canarias, Spain

H. de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

H. de Navarra; 🇪🇸 Pamplona, Navarra, Spain