ID

33820

Descripción

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01718145

Link

https://clinicaltrials.gov/show/NCT01718145

Palabras clave

Versiones (1)
  1. 2/1/19 2/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus Infection NCT01718145

Inglés

Eligibility Hepatitis C Virus Infection NCT01718145

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv-1b infected patient
Descripción

Chronic Hepatitis C HCV 1b

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C3494965
hcv ribonucleic acid (rna) > 100,000 iu/ml at screening
Descripción

Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272251
ages 20 to 70 years (for the naive cohort), ages 20 to 75 years (for the relapser cohort)
Descripción

Age | Cohort Therapy naive | Cohort Recurrent disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0599755
UMLS CUI [2,2]
C0919936
UMLS CUI [3,1]
C0599755
UMLS CUI [3,2]
C0277556
treatment naive subjects to interferon (ifn) based therapy
Descripción

Interferon therapy naive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0919936
subjects who had undetectable hcv rna at end of treatment with prior exposure to an ifn-containing regimen, but hcv rna detectable within 24 weeks of treatment follow-up
Descripción

Hepatitis C virus RNA Undetectable | Exposure to Interferon therapy | Hepatitis C virus RNA Detectable Follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C3827727
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0279030
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C3830527
UMLS CUI [3,3]
C3274571
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have;
Descripción

Patients Have

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
hepatocellular carcinoma
Descripción

Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Descripción

HBV coinfection | HIV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
severe or uncontrollable complication
Descripción

Severe complication | Complication Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3495031
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0205318
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Similar models

Eligibility Hepatitis C Virus Infection NCT01718145

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C HCV 1b
Item
chronic hcv-1b infected patient
boolean
C0524910 (UMLS CUI [1,1])
C3494965 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv ribonucleic acid (rna) > 100,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Age | Cohort Therapy naive | Cohort Recurrent disease
Item
ages 20 to 70 years (for the naive cohort), ages 20 to 75 years (for the relapser cohort)
boolean
C0001779 (UMLS CUI [1])
C0599755 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C0599755 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
Interferon therapy naive
Item
treatment naive subjects to interferon (ifn) based therapy
boolean
C0279030 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Hepatitis C virus RNA Undetectable | Exposure to Interferon therapy | Hepatitis C virus RNA Detectable Follow-up
Item
subjects who had undetectable hcv rna at end of treatment with prior exposure to an ifn-containing regimen, but hcv rna detectable within 24 weeks of treatment follow-up
boolean
C0369335 (UMLS CUI [1,1])
C3827727 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0279030 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Patients Have
Item
patients who have;
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Severe complication | Complication Uncontrolled
Item
severe or uncontrollable complication
boolean
C3495031 (UMLS CUI [1])
C0009566 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Volver a la parte superior de la página 

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