Clinical trial NCT02004379: Register of Telaprevir and Boceprevir in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: HCV
Hepatitis C
telaprevir
boceprevir
clinical practice
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 1553
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C, genotype 1, who are elegible to be treated with telaprevir or boceprevir

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Doctor Negrín
state: Gran Canaria
city: Motril
country: Spain
facility: Hospital Comarcal Santa Ana
state: Granada
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
state: La Coruña
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Mallorca
city: Lorca
country: Spain
facility: Hospital General Universitario Rafael Méndez
state: Murcia
city: Marbella
country: Spain
facility: Agencia Sanitaria Costa del Sol
state: Málaga
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de la Candelaria
state: Tenerife
city: Almería
country: Spain
facility: Hospital de Poniente
city: Almería
country: Spain
facility: Hospital Torrecárdenas
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario de San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Guadalajara
country: Spain
facility: Hospital de Guadalajara
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Huesca
country: Spain
facility: Hospital San Jorge
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: La Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Murcia
country: Spain
facility: Hospital Reina Sofía
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Unviersitario Virgen del Rocío
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital la Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zamora
country: Spain
facility: Hospital de Zamora
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario de Zaragoza
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Universitario de San Cecilio
name: Javier Salmerón Escobar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmeron J, Vinaixa C, Berenguer R, Pascasio JM, Sanchez Ruano JJ, Serra MA, Gila A, Diago M, Romero-Gomez M, Navarro JM, Testillano M, Fernandez C, Espinosa D, Carmona I, Pons JA, Jorquera F, Rodriguez FJ, Perez R, Montero JL, Granados R, Fernandez M, Martin AB, Munoz de Rueda P, Quiles R; Alhambra Spanish Study Group. Effectiveness and safety of first-generation protease inhibitors in clinical practice: Hepatitis C virus patients with advanced fibrosis. World J Gastroenterol. 2015 Aug 14;21(30):9163-74. doi: 10.3748/wjg.v21.i30.9163.