- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01980290
Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C (INTEGRATE)
Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania
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Biberach, Alemania
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Kassel, Alemania
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München, Alemania
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Münster, Alemania
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Antwerpen, Bélgica
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Brussels, Bélgica
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Bruxelles, Bélgica
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Genk, Bélgica
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Haine-Saint-Paul, Bélgica
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Lomme, Francia
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Montpellier, Francia
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Perpignan Cedex, Francia
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Maastricht, Países Bajos
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Dundee, Reino Unido
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London, Reino Unido
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Nottingham, Reino Unido
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Lausanne, Suiza
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Zürich, Suiza
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Have HCV genotype 1, a quantifiable serum HCV RNA, recent (within 18 months of baseline) documentation of the degree of liver fibrosis (Metavir F0-F4; Ishak 0-6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan); Physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV; Have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers); History of injecting drugs and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center.
Exclusion Criteria:
Infected or coinfected with HCV of a genotype other than genotype 1; Previous or current treatment with a DAA therapy; Have any contraindication specified in the SmPC for telaprevir, PegIFN alfa, or RBV; Have a history or other evidence of decompensated liver disease, or have coinfection with active hepatitis B or HIV; Currently participating in another investigational study or clinical study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sustained Virologic Response at 12 weeks (SVR12)
Periodo de tiempo: Week 12
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HCV RNA <25 IU/mL, at 12 weeks (SVR12) after the last dose of anti-HCV treatment (telaprevir, PegIFN alfa, RBV)
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Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
adherence to telaprevir until Week 12
Periodo de tiempo: week 12
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adherence as measured by pill count and/or patient questionnaire (modified medication adherence self-report inventory [M-MASRI]
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week 12
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adherence to PegIFN alfa and RBV
Periodo de tiempo: at end of treatment (week 24)
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adherence as measured by pill/vial count and/or patient questionnaire (M-MASRI)
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at end of treatment (week 24)
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on-treatment virologic response undetectable
Periodo de tiempo: week 12 and end of treatment ()
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rapid virologic response [RVR] and extended rapid virologic response [eRVR], Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL undetectable
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week 12 and end of treatment ()
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on treatment virologic response
Periodo de tiempo: week 12 and end of treatment ()
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rapid virologic response [RVR] and extended rapid virologic response [eRVR], Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL
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week 12 and end of treatment ()
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health-related quality of life based on EQ-5D
Periodo de tiempo: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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The EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses.
The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems).
A standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state is also included ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
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on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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HADS is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression.
Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety.
Cases of anxiety or depression are each defined by subscale scores of 8 or greater, and categorized as normal (score of 0-7), mild (score of 8-10), moderate (score of 11-14), and severe (score of 15-21).
The recall period is the past week.
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on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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alcohol use disorders identification test (AUDIT)
Periodo de tiempo: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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The AUDIT questionnaire consists of 10 questions about a patient's quantity and frequency of alcohol use.
The response to 8 of the questions are scored as 0 = never, 1 = monthly or less, 2 = 2 to 4 times a month, 3 = 2 to 3 times a week, 4 = 4 or more times a week.
Two questions are scored as 0 = no, 2 = yes, but not in the last year, 4 = yes, during the last year.
A score of 8 or more is associated with harmful or hazardous drinking
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on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis Crónica
- Hepatitis C Crónica
Otros números de identificación del estudio
- CR100966
- VX-950HPC4017 (Otro identificador: Janssen Pharmaceutica NV - CTMS ID)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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