ID

34327

Descripción

Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01170962

Link

https://clinicaltrials.gov/show/NCT01170962

Palabras clave

Versiones (1)
  1. 16/1/19 16/1/19 -
Titular de derechos de autor

see on clinicaltrials.gov

Subido en

16 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01170962

Inglés

Eligibility Hepatitis C Virus NCT01170962

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv genotype 1
Descripción

ID.1

Tipo de datos

boolean

non-responder to prior therapy with peginterferon alfa and ribavirin
Descripción

ID.2

Tipo de datos

boolean

hcv rna viral load of ≥ 100,00 iu/ml
Descripción

ID.3

Tipo de datos

boolean

results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic hcv infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics will be capped at 10% of randomized study population)
Descripción

ID.4

Tipo de datos

boolean

ultrasound, ct scan or mri results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
Descripción

ID.5

Tipo de datos

boolean

body mass index (bmi) of 18 to 35 kg/m2
Descripción

ID.6

Tipo de datos

boolean

Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive for hepatitis b infection (hbsag) or hiv-1/hiv-2 antibody at screening
Descripción

ID.7

Tipo de datos

boolean

evidence of medical condition associated with chronic liver disease other than hcv
Descripción

ID.8

Tipo de datos

boolean

evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Descripción

ID.9

Tipo de datos

boolean

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Similar models

Eligibility Hepatitis C Virus NCT01170962

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
subjects chronically infected with hcv genotype 1
boolean
ID.2
Item
non-responder to prior therapy with peginterferon alfa and ribavirin
boolean
ID.3
Item
hcv rna viral load of ≥ 100,00 iu/ml
boolean
ID.4
Item
results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic hcv infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics will be capped at 10% of randomized study population)
boolean
ID.5
Item
ultrasound, ct scan or mri results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
boolean
ID.6
Item
body mass index (bmi) of 18 to 35 kg/m2
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
positive for hepatitis b infection (hbsag) or hiv-1/hiv-2 antibody at screening
boolean
ID.8
Item
evidence of medical condition associated with chronic liver disease other than hcv
boolean
ID.9
Item
evidence of decompensated cirrhosis based on radiologic criteria or biopsy
boolean
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