Register of Telaprevir and Boceprevir in Routine Clinical Practice

Sponsor

Fundación Pública Andaluza Progreso y Salud (Other)

Overall Status

Completed

CT.gov ID

NCT02004379

Collaborator

(none)

1,553

Enrollment

Locations

Duration (Months)

32.4

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1553 participants

Observational Model:

Cohort

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Patients with hepatitis C, genotype 1 Patients with hepatitis C, genotype 1, treated with telaprevir or boceprevir

Outcome Measures

Primary Outcome Measures

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 [12 months]
Know through routine clinical practice the percentage of patients who have negative VHC-ARN
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 [12 months]
Number and frequencies of serious adverse event (SAE) during the treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Universitario Doctor Negrín	Las Palmas de Gran Canaria	Gran Canaria	Spain
2	Hospital Comarcal Santa Ana	Motril	Granada	Spain
3	Hospital Universitario de Santiago de Compostela	Santiago de Compostela	La Coruña	Spain
4	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid	Spain
5	Hospital Son Espases	Palma de Mallorca	Mallorca	Spain
6	Hospital General Universitario Rafael Méndez	Lorca	Murcia	Spain
7	Agencia Sanitaria Costa del Sol	Marbella	Málaga	Spain
8	Hospital Universitario Nuestra Señora de la Candelaria	Santa Cruz de Tenerife	Tenerife	Spain
9	Hospital de Poniente	Almería		Spain
10	Hospital Torrecárdenas	Almería		Spain
11	Hospital Infanta Cristina	Badajoz		Spain
12	Hospital Universitario de Cruces	Bilbao		Spain
13	Hospital General de Ciudad Real	Ciudad Real		Spain
14	Hospital San Pedro de Alcántara	Cáceres		Spain
15	Hospital Puerta del Mar	Cádiz		Spain
16	Hospital Reina Sofía	Córdoba		Spain
17	Hospital Universitario de San Cecilio	Granada		Spain
18	Hospital Universitario Virgen de las Nieves	Granada		Spain
19	Hospital de Guadalajara	Guadalajara		Spain
20	Hospital Juan Ramón Jiménez	Huelva		Spain
21	Hospital San Jorge	Huesca		Spain
22	Complejo Hospitalario de Jaén	Jaén		Spain
23	Hospital Universitario A Coruña	La Coruña		Spain
24	Hospital de León	León		Spain
25	Hospital Ramón y Cajal	Madrid		Spain
26	Hospital Universitario de La Princesa	Madrid		Spain
27	Hospital Universitario La Paz	Madrid		Spain
28	Hospital Morales Meseguer	Murcia		Spain
29	Hospital Reina Sofía	Murcia		Spain
30	Hospital Universitario Virgen de la Arrixaca	Murcia		Spain
31	Hospital Universitario Carlos Haya	Málaga		Spain
32	Hospital Universitario Virgen de la Victoria	Málaga		Spain
33	Hospital Universitario Central de Asturias	Oviedo		Spain
34	Hospital Universitario de Salamanca	Salamanca		Spain
35	Hospital Universitario de Donostia	San Sebastián		Spain
36	Hospital Universitario de Valme	Sevilla		Spain
37	Hospital Universitario Virgen de la Macarena	Sevilla		Spain
38	Hospital Unviersitario Virgen del Rocío	Sevilla		Spain
39	Complejo Hospitalario de Toledo	Toledo		Spain
40	Hospital Arnau de Vilanova	Valencia		Spain
41	Hospital Clínico de Valencia	Valencia		Spain
42	Hospital General de Valencia	Valencia		Spain
43	Hospital la Fe	Valencia		Spain
44	Hospital Clínico Universitario de Valladolid	Valladolid		Spain
45	Hospital Universitario Río Hortega	Valladolid		Spain
46	Hospital de Zamora	Zamora		Spain
47	Hospital Clínico Universitario de Zaragoza	Zaragoza		Spain
48	Hospital Universitario Miguel Servet	Zaragoza		Spain