Register of Telaprevir and Boceprevir in Routine Clinical Practice

Hepatitis C Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004379
• Other study ID #: FPS-TEL-2013-01
• Status: Completed
• Phase: N/A
• First received: November 20, 2013
• Last updated: July 14, 2015
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1553
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Hepatitis C

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital de Poniente	Almería
Spain	Hospital Torrecárdenas	Almería
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitario de Cruces	Bilbao
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Universitario de San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital de Guadalajara	Guadalajara
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital San Jorge	Huesca
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario A Coruña	La Coruña
Spain	Hospital Universitario Doctor Negrín	Las Palmas de Gran Canaria	Gran Canaria
Spain	Hospital de León	León
Spain	Hospital General Universitario Rafael Méndez	Lorca	Murcia
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Carlos Haya	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Agencia Sanitaria Costa del Sol	Marbella	Málaga
Spain	Hospital Comarcal Santa Ana	Motril	Granada
Spain	Hospital Morales Meseguer	Murcia
Spain	Hospital Reina Sofía	Murcia
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Son Espases	Palma de Mallorca	Mallorca
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario de Donostia	San Sebastián
Spain	Hospital Universitario Nuestra Señora de la Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Universitario de Santiago de Compostela	Santiago de Compostela	La Coruña
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Unviersitario Virgen del Rocío	Sevilla
Spain	Complejo Hospitalario de Toledo	Toledo
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital General de Valencia	Valencia
Spain	Hospital la Fe	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario Río Hortega	Valladolid
Spain	Hospital de Zamora	Zamora
Spain	Hospital Clínico Universitario de Zaragoza	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Know through routine clinical practice the percentage of patients who have negative VHC-ARN	12 months	Yes
Primary	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	Number and frequencies of serious adverse event (SAE) during the treatment	12 months	Yes