ID

39685

Descripción

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02023099

Link

https://clinicaltrials.gov/show/NCT02023099

Palabras clave

Versiones (1)
  1. 2020-02-10 2020-02-10 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 februari 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Hepatitis C Virus NCT02023099

Inglés

Eligibility Hepatitis C Virus NCT02023099

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv-infection prior to study enrollment
Descripción

Hepatitis C, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524910
screening laboratory result indicating hcv subgenotype 1b infection
Descripción

Laboratory Results | Indication Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0019196
UMLS CUI [2,3]
C1533728
subject has plasma hcv rna level greater than 10,000 iu/ml at screening
Descripción

Hepatitis C virus RNA assay Plasma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
voluntarily sign an informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection of hepatitis b virus (hbv), hiv and any hcv genotype other than subgenotype 1b
Descripción

HBV coinfection | HIV coinfection | HCV coinfection Genotype | Exception Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
UMLS CUI [3,1]
C1698259
UMLS CUI [3,2]
C1533728
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1533728
prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir
Descripción

Prior Therapy Hepatitis C | DIRECT ACTING ANTIVIRALS | telaprevir | simeprevir | boceprevir

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C3653501
UMLS CUI [3]
C1876229
UMLS CUI [4]
C2605855
UMLS CUI [5]
C1738934
any cause of liver disease other than chronic hcv-infection, including but not limited to the following:
Descripción

Liver disease | Etiology Except Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0524910
hemochromatosis
Descripción

Hemochromatosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018995
alpha-1 antitrypsin deficiency
Descripción

Alpha-1 Antitrypsin Deficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221757
wilson's disease
Descripción

Hepatolenticular Degeneration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019202
autoimmune hepatitis
Descripción

Hepatitis, Autoimmune

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0241910
alcoholic liver disease
Descripción

Alcoholic Liver Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023896
drug-related liver disease
Descripción

Drug-Induced Liver Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0860207
clinically significant laboratory abnormalities
Descripción

Laboratory test result abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
uncontrolled clinically significant disease, disorder or medical illness
Descripción

Disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
Volver a la parte superior de la página

Similar models

Eligibility Hepatitis C Virus NCT02023099

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
chronic hcv-infection prior to study enrollment
boolean
C0524910 (UMLS CUI [1])
Laboratory Results | Indication Hepatitis C Genotype
Item
screening laboratory result indicating hcv subgenotype 1b infection
boolean
C1254595 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1533728 (UMLS CUI [2,3])
Hepatitis C virus RNA assay Plasma
Item
subject has plasma hcv rna level greater than 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Informed Consent
Item
voluntarily sign an informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HBV coinfection | HIV coinfection | HCV coinfection Genotype | Exception Genotype
Item
co-infection of hepatitis b virus (hbv), hiv and any hcv genotype other than subgenotype 1b
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1533728 (UMLS CUI [4,2])
Prior Therapy Hepatitis C | DIRECT ACTING ANTIVIRALS | telaprevir | simeprevir | boceprevir
Item
prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir
boolean
C1514463 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C3653501 (UMLS CUI [2])
C1876229 (UMLS CUI [3])
C2605855 (UMLS CUI [4])
C1738934 (UMLS CUI [5])
Liver disease | Etiology Except Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv-infection, including but not limited to the following:
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Hemochromatosis
Item
hemochromatosis
boolean
C0018995 (UMLS CUI [1])
Alpha-1 Antitrypsin Deficiency
Item
alpha-1 antitrypsin deficiency
boolean
C0221757 (UMLS CUI [1])
Hepatolenticular Degeneration
Item
wilson's disease
boolean
C0019202 (UMLS CUI [1])
Hepatitis, Autoimmune
Item
autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Alcoholic Liver Disease
Item
alcoholic liver disease
boolean
C0023896 (UMLS CUI [1])
Drug-Induced Liver Disease
Item
drug-related liver disease
boolean
C0860207 (UMLS CUI [1])
Laboratory test result abnormal
Item
clinically significant laboratory abnormalities
boolean
C0438215 (UMLS CUI [1])
Disease Uncontrolled
Item
uncontrolled clinically significant disease, disorder or medical illness
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial