ID

35976

Descripción

A Study of Treatment With RO6864018 in Entecavir-Treated Patients With Chronic Hepatitis B Virus (HBV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02391805

Link

https://clinicaltrials.gov/show/NCT02391805

Palabras clave

Versiones (1)
  1. 8/4/19 8/4/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de abril de 2019

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 B, Chronic NCT02391805

Inglés

Eligibility Hepatitis B, Chronic NCT02391805

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 to 65 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
chronic hepatitis b infection
Descripción

Hepatitis B, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524909
positive test for hbsag for more than 6 months prior to randomization
Descripción

Hepatitis B surface antigen positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149709
hbsag titer greater than or equal to 250 iu/ml at screening
Descripción

Hepatitis B Surface Antigens Titer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0475208
treatment with any nucleoside/nucleotide analogue for 1 to 3 years with ongoing entecavir treatment at randomization and for at least 6 months prior to randomization
Descripción

Nucleoside Analogs | Nucleotide analog | entecavir

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2]
C0597107
UMLS CUI [3]
C0971023
hbv dna less than 90 iu/ml or below a detection level acceptable by both the sponsor and the investigator for at least the preceding 6 months
Descripción

Hepatitis B DNA Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3641250
hbeag positive at randomization and for at least 6 months prior to randomization
Descripción

Hepatitis B e antigen positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392390
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
documented history of hbv genotype d
Descripción

Hepatitis B virus genotype D

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3875365
history or other evidence of bleeding from esophageal varices
Descripción

Bleeding esophageal varices

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155789
history of decompensated liver disease, chronic liver disease other than hbv infection, or any evidence of metabolic liver disease
Descripción

End Stage Liver Disease | Chronic liver disease | Exception Hepatitis B | Liver disease Metabolic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019163
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0311400
positive test for hepatitis a, hepatitis c, or human immunodeficiency virus (hiv)
Descripción

Hepatitis A test positive | Hepatitis C test positive | HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0560226
UMLS CUI [2]
C1609517
UMLS CUI [3]
C0019699
documented history of hepatitis d, e, or g infection
Descripción

Hepatitis D Infection | Hepatitis E | Hepatitis G

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011226
UMLS CUI [2]
C0085293
UMLS CUI [3]
C0814152
history of or suspicion of hepatocellular carcinoma
Descripción

Liver carcinoma | Suspicion Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C2239176
history of immunologically mediated disease
Descripción

Disease Immune-mediated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4330477
history of organ transplantation
Descripción

Organ Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029216
history of thyroid disease
Descripción

Thyroid Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040128
significant acute infection
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
Volver a la parte superior de la página

Similar models

Eligibility Hepatitis B, Chronic NCT02391805

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 to 65 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis B, Chronic
Item
chronic hepatitis b infection
boolean
C0524909 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
positive test for hbsag for more than 6 months prior to randomization
boolean
C0149709 (UMLS CUI [1])
Hepatitis B Surface Antigens Titer
Item
hbsag titer greater than or equal to 250 iu/ml at screening
boolean
C0019168 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
Nucleoside Analogs | Nucleotide analog | entecavir
Item
treatment with any nucleoside/nucleotide analogue for 1 to 3 years with ongoing entecavir treatment at randomization and for at least 6 months prior to randomization
boolean
C1579410 (UMLS CUI [1])
C0597107 (UMLS CUI [2])
C0971023 (UMLS CUI [3])
Hepatitis B DNA Measurement
Item
hbv dna less than 90 iu/ml or below a detection level acceptable by both the sponsor and the investigator for at least the preceding 6 months
boolean
C3641250 (UMLS CUI [1])
Hepatitis B e antigen positive
Item
hbeag positive at randomization and for at least 6 months prior to randomization
boolean
C0392390 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B virus genotype D
Item
documented history of hbv genotype d
boolean
C3875365 (UMLS CUI [1])
Bleeding esophageal varices
Item
history or other evidence of bleeding from esophageal varices
boolean
C0155789 (UMLS CUI [1])
End Stage Liver Disease | Chronic liver disease | Exception Hepatitis B | Liver disease Metabolic
Item
history of decompensated liver disease, chronic liver disease other than hbv infection, or any evidence of metabolic liver disease
boolean
C0745744 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0311400 (UMLS CUI [4,2])
Hepatitis A test positive | Hepatitis C test positive | HIV Seropositivity
Item
positive test for hepatitis a, hepatitis c, or human immunodeficiency virus (hiv)
boolean
C0560226 (UMLS CUI [1])
C1609517 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Hepatitis D Infection | Hepatitis E | Hepatitis G
Item
documented history of hepatitis d, e, or g infection
boolean
C0011226 (UMLS CUI [1])
C0085293 (UMLS CUI [2])
C0814152 (UMLS CUI [3])
Liver carcinoma | Suspicion Liver carcinoma
Item
history of or suspicion of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Disease Immune-mediated
Item
history of immunologically mediated disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
Organ Transplantation
Item
history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
Thyroid Disease
Item
history of thyroid disease
boolean
C0040128 (UMLS CUI [1])
Communicable Disease
Item
significant acute infection
boolean
C0009450 (UMLS CUI [1])
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