ID

39680

Descripción

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir; ODM derived from: https://clinicaltrials.gov/show/NCT01598090

Link

https://clinicaltrials.gov/show/NCT01598090

Palabras clave

Versiones (1)
  1. 9/2/20 9/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de febrero 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 NCT01598090

Inglés

Eligibility Hepatitis C Virus NCT01598090

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c genotype 1. gt-1b capped at 50 % of naïve subjects
Descripción

Chronic Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
naives to prior anti-hcv therapy [interferon (ifn) and direct antiviral agent (daa) based]
Descripción

Anti-hepatitis C (HCV) Agents Absent | Interferon Absent | DIRECT ACTING ANTIVIRALS Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4324240
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3653501
UMLS CUI [3,2]
C0332197
relapsers (defined as subjects who had undetectable hcv ribonucleic acid (rna) on prior treatment regimen of alfa-2a/rbv and hepatitis c virus (hcv) rna > 25iu/ml after discontinuation of treatment). capped at 20%
Descripción

Recurrent disease | Hepatitis C virus RNA Undetectable | Status post Interferon Alfa-2a Ribavirin | Hepatitis C virus RNA assay | Status post Therapeutic procedure Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3827727
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0021734
UMLS CUI [3,3]
C0035525
UMLS CUI [4]
C1272251
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C1444662
hcv rna ≥ 100,000 iu/ml
Descripción

Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272251
subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
Descripción

Compensated cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1608426
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag)
Descripción

HIV Seronegative | Hepatitis B Surface Antigens Seronegative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521144
men or women, 18-70 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic liver disease due to causes other than chronic hcv
Descripción

Chronic liver disease | Etiology Except Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0524910
current or past evidence of decompensation
Descripción

Decompensation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0231187
conditions that preclude the use of alfa/rbv/tvr per respective labels
Descripción

Condition Excludes Interferon-alpha | Condition Excludes Ribavirin | Condition Excludes Telaprevir

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0002199
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1876229
diagnosed or suspected hepatocellular carcinoma
Descripción

Liver carcinoma | Liver carcinoma Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
Volver a la parte superior de la página

Similar models

Eligibility Hepatitis C Virus NCT01598090

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
chronic hepatitis c genotype 1. gt-1b capped at 50 % of naïve subjects
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Anti-hepatitis C (HCV) Agents Absent | Interferon Absent | DIRECT ACTING ANTIVIRALS Absent
Item
naives to prior anti-hcv therapy [interferon (ifn) and direct antiviral agent (daa) based]
boolean
C4324240 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3653501 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Recurrent disease | Hepatitis C virus RNA Undetectable | Status post Interferon Alfa-2a Ribavirin | Hepatitis C virus RNA assay | Status post Therapeutic procedure Discontinued
Item
relapsers (defined as subjects who had undetectable hcv ribonucleic acid (rna) on prior treatment regimen of alfa-2a/rbv and hepatitis c virus (hcv) rna > 25iu/ml after discontinuation of treatment). capped at 20%
boolean
C0277556 (UMLS CUI [1])
C0369335 (UMLS CUI [2,1])
C3827727 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0021734 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C1272251 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1444662 (UMLS CUI [5,3])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 100,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Compensated cirrhosis
Item
subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
boolean
C1608426 (UMLS CUI [1])
HIV Seronegative | Hepatitis B Surface Antigens Seronegative
Item
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag)
boolean
C0019682 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
Age
Item
men or women, 18-70 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic liver disease | Etiology Except Chronic Hepatitis C
Item
chronic liver disease due to causes other than chronic hcv
boolean
C0341439 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Decompensation
Item
current or past evidence of decompensation
boolean
C0231187 (UMLS CUI [1])
Condition Excludes Interferon-alpha | Condition Excludes Ribavirin | Condition Excludes Telaprevir
Item
conditions that preclude the use of alfa/rbv/tvr per respective labels
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0002199 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1876229 (UMLS CUI [3,3])
Liver carcinoma | Liver carcinoma Suspected
Item
diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
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