- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00812331
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
1 de julio de 2014 actualizado por: Tibotec Pharmaceuticals, Ireland
An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.
The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.
Descripción general del estudio
Descripción detallada
This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435.
Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group).
The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication).
Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.
Tipo de estudio
Intervencionista
Inscripción (Actual)
37
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
- Participants who have never received treatment for their HCV infection
- Participants with either no cirrhosis or up to Child Pugh A liver disease
- Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening
Exclusion Criteria:
- Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
- Participants with diagnosed or suspected hepatocellular carcinoma
- Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
- Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Genotype 2
Participants with chronic genotype 2 hepatitis C virus (HCV) infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
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Experimental: Genotype 3
Participants with chronic genotype 3 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Experimental: Genotype 4
Participants with chronic genotype 4 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Experimental: Genotype 5
Participants with chronic genotype 5 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Experimental: Genotype 6
Participants with chronic genotype 6 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
Periodo de tiempo: Baseline, Day 3, and Day 7
|
The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.
|
Baseline, Day 3, and Day 7
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period
Periodo de tiempo: Baseline, Day 3, Day 5 and Day 7
|
The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.
|
Baseline, Day 3, Day 5 and Day 7
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Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period
Periodo de tiempo: Baseline, Day 3, Day 5 and Day 7
|
The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.
|
Baseline, Day 3, Day 5 and Day 7
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Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
Periodo de tiempo: During the 7-day of TMC435 treatment period
|
The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.
|
During the 7-day of TMC435 treatment period
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Predose Plasma Concentration (C0h) of TMC435
Periodo de tiempo: Predose on Day 7
|
The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.
|
Predose on Day 7
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Minimum Plasma Concentration (Cmin) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Maximum Plasma Concentration (Cmax) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Average Steady-State Plasma Concentration (Css,av) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Fluctuation Index (FI) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Elimination Rate Constant of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Terminal Elimination Half-life (t1/2,Term) of TMC435
Periodo de tiempo: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection.
The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2009
Finalización primaria (Actual)
1 de noviembre de 2009
Finalización del estudio (Actual)
1 de noviembre de 2009
Fechas de registro del estudio
Enviado por primera vez
18 de diciembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
18 de diciembre de 2008
Publicado por primera vez (Estimar)
22 de diciembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de julio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
1 de julio de 2014
Última verificación
1 de julio de 2014
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
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Inhibidores de la proteasa
- Simeprevir
Otros números de identificación del estudio
- CR012604
- TMC435350-TiDP16-C202 (Otro identificador: Tibotec Pharmaceuticals, Ireland)
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. .
Ensayos clínicos sobre Hepatitis C
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Trek Therapeutics, PBCTerminadoHepatitis C Crónica | Hepatitis C Genotipo 1 | Hepatitis C (VHC) | Infección viral de la hepatitis CEstados Unidos, Nueva Zelanda
-
Trek Therapeutics, PBCTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 4 | Infección viral de la hepatitis CEstados Unidos
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AbbVieTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 1a
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AbbVie (prior sponsor, Abbott)TerminadoHepatitis C Crónica | Hepatitis C Genotipo 1 | Hepatitis C (VHC)Estados Unidos, Australia, Canadá, Francia, Alemania, Nueva Zelanda, Puerto Rico, España, Reino Unido
-
AbbVieTerminadoVirus de la hepatitis C | Virus de la hepatitis C crónica
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AbbVie (prior sponsor, Abbott)TerminadoHepatitis C | Infección crónica por hepatitis C | VHC | Hepatitis C Genotipo 1Estados Unidos
-
AbbVieTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 1a
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Humanity and Health Research CentreBeijing 302 HospitalTerminadoInfección crónica por hepatitis CPorcelana
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University Health Network, TorontoTerminadoInfección crónica por hepatitis CCanadá
-
AbbVie (prior sponsor, Abbott)TerminadoHepatitis C | Infección crónica por hepatitis C | VHC | Hepatitis C Genotipo 1Estados Unidos, Puerto Rico
Ensayos clínicos sobre TMC435
-
Tibotec Pharmaceuticals, IrelandTerminado
-
Janssen Research & Development, LLCTerminado
-
Tibotec Pharmaceuticals, IrelandTerminado
-
Janssen R&D IrelandTerminado
-
Tibotec Pharmaceuticals, IrelandTerminado
-
Janssen R&D IrelandTerminadoHepatitis CEstados Unidos, Australia, Francia, Ucrania, Reino Unido, Bélgica, Alemania, España, Israel, Portugal, Bulgaria, Países Bajos, Canadá, Nueva Zelanda, Federación Rusa, Argentina, Brasil, Puerto Rico, Austria, Polonia, Rumania, México
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Tibotec Pharmaceuticals, IrelandTerminado
-
Tibotec Pharmaceuticals, IrelandTerminadoVirus de la hepatitis CRepública Checa
-
Tibotec Pharmaceuticals, IrelandTerminado
-
Janssen R&D IrelandTerminadoVoluntarios SaludablesReino Unido