ID

40906

Descripción

Ph IIA Study (SOC +/- NS5B); ODM derived from: https://clinicaltrials.gov/show/NCT01193361

Link

https://clinicaltrials.gov/show/NCT01193361

Palabras clave

Versiones (1)
  1. 2/6/20 2/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de junio de 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 NCT01193361

Inglés

Eligibility Hepatitis C Virus NCT01193361

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv genotype 1 as documented by: positive for anti-hcv antibody, hcv rna, or a positive hcv genotype test at least 6 months prior to screening, and positive for hcv rna and anti-hcv antibody at screening
Descripción

Chronic Hepatitis C Genotype | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis c viral genotype Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0855842
UMLS CUI [4,1]
C4272868
UMLS CUI [4,2]
C1514241
hcv rna ≥ 10*5* iu/ml at screening
Descripción

Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272251
less than 4 weeks total prior therapy with an ifn formulation (ie, ifnα, pegifnα-2a), or rbv and no exposure to ifn or rbv within 24 weeks of randomization
Descripción

Prior Therapy | Interferon Formulation | Interferon-alpha | peginterferon alfa-2a | Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0524527
UMLS CUI [3]
C0002199
UMLS CUI [4]
C0391001
UMLS CUI [5]
C0035525
results of a biopsy obtained ≤ 24 months prior to randomization showing no evidence of cirrhosis
Descripción

Liver Cirrhosis Absent Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0005558
body mass index (bmi) of 18 to 35 kg/m², inclusive. bmi = weight (kg)/ [height (m)]²
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
at screening
Descripción

ID.6

Tipo de datos

boolean

Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
liver transplant recipients
Descripción

Recipient Liver transplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0023911
documented or suspected hcc by imaging or liver biopsy
Descripción

Liver carcinoma Imaging | Liver carcinoma Suspected Imaging | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0011923
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0193388
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0193388
evidence of a medical condition associated with chronic liver disease other than hcv (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
Descripción

Medical condition Associated with Chronic liver disease | Exception Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Disease | Exposure to Toxin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0241910
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0311400
UMLS CUI [6]
C0023896
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C0040549
history of chronic hepatitis b virus (hbv) as documented by hbv serologies (eg. hbsag-seropositive). patients with resolved hbv infection may participate (eg. hbsab-seropositive)
Descripción

Hepatitis B, Chronic | Hepatitis b serology | Hepatitis B Surface Antigens Seropositive | Hepatitis B resolved | Hepatitis B Virus Surface Antibody Seropositive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0744837
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C0521143
UMLS CUI [4,1]
C0019163
UMLS CUI [4,2]
C1514893
UMLS CUI [5,1]
C0369334
UMLS CUI [5,2]
C0521143
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Descripción

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
Volver a la parte superior de la página

Similar models

Eligibility Hepatitis C Virus NCT01193361

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis c viral genotype Positive
Item
subjects chronically infected with hcv genotype 1 as documented by: positive for anti-hcv antibody, hcv rna, or a positive hcv genotype test at least 6 months prior to screening, and positive for hcv rna and anti-hcv antibody at screening
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0281863 (UMLS CUI [2])
C0855842 (UMLS CUI [3])
C4272868 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10*5* iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Prior Therapy | Interferon Formulation | Interferon-alpha | peginterferon alfa-2a | Ribavirin
Item
less than 4 weeks total prior therapy with an ifn formulation (ie, ifnα, pegifnα-2a), or rbv and no exposure to ifn or rbv within 24 weeks of randomization
boolean
C1514463 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0002199 (UMLS CUI [3])
C0391001 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
Liver Cirrhosis Absent Biopsy
Item
results of a biopsy obtained ≤ 24 months prior to randomization showing no evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) of 18 to 35 kg/m², inclusive. bmi = weight (kg)/ [height (m)]²
boolean
C1305855 (UMLS CUI [1])
ID.6
Item
at screening
boolean
Item Group
C0680251 (UMLS CUI)
Recipient Liver transplant
Item
liver transplant recipients
boolean
C1709854 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
Liver carcinoma Imaging | Liver carcinoma Suspected Imaging | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver
Item
documented or suspected hcc by imaging or liver biopsy
boolean
C2239176 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
Medical condition Associated with Chronic liver disease | Exception Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Disease | Exposure to Toxin
Item
evidence of a medical condition associated with chronic liver disease other than hcv (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0018995 (UMLS CUI [3])
C0241910 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0311400 (UMLS CUI [5,2])
C0023896 (UMLS CUI [6])
C0332157 (UMLS CUI [7,1])
C0040549 (UMLS CUI [7,2])
Hepatitis B, Chronic | Hepatitis b serology | Hepatitis B Surface Antigens Seropositive | Hepatitis B resolved | Hepatitis B Virus Surface Antibody Seropositive
Item
history of chronic hepatitis b virus (hbv) as documented by hbv serologies (eg. hbsag-seropositive). patients with resolved hbv infection may participate (eg. hbsab-seropositive)
boolean
C0524909 (UMLS CUI [1])
C0744837 (UMLS CUI [2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C1514893 (UMLS CUI [4,2])
C0369334 (UMLS CUI [5,1])
C0521143 (UMLS CUI [5,2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
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