ID

39685

Beskrivning

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02023099

Länk

https://clinicaltrials.gov/show/NCT02023099

Nyckelord

  1. 2020-02-10 2020-02-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 februari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatitis C Virus NCT02023099

Eligibility Hepatitis C Virus NCT02023099

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv-infection prior to study enrollment
Beskrivning

Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0524910
screening laboratory result indicating hcv subgenotype 1b infection
Beskrivning

Laboratory Results | Indication Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0019196
UMLS CUI [2,3]
C1533728
subject has plasma hcv rna level greater than 10,000 iu/ml at screening
Beskrivning

Hepatitis C virus RNA assay Plasma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
voluntarily sign an informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection of hepatitis b virus (hbv), hiv and any hcv genotype other than subgenotype 1b
Beskrivning

HBV coinfection | HIV coinfection | HCV coinfection Genotype | Exception Genotype

Datatyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
UMLS CUI [3,1]
C1698259
UMLS CUI [3,2]
C1533728
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1533728
prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir
Beskrivning

Prior Therapy Hepatitis C | DIRECT ACTING ANTIVIRALS | telaprevir | simeprevir | boceprevir

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C3653501
UMLS CUI [3]
C1876229
UMLS CUI [4]
C2605855
UMLS CUI [5]
C1738934
any cause of liver disease other than chronic hcv-infection, including but not limited to the following:
Beskrivning

Liver disease | Etiology Except Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0524910
hemochromatosis
Beskrivning

Hemochromatosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0018995
alpha-1 antitrypsin deficiency
Beskrivning

Alpha-1 Antitrypsin Deficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0221757
wilson's disease
Beskrivning

Hepatolenticular Degeneration

Datatyp

boolean

Alias
UMLS CUI [1]
C0019202
autoimmune hepatitis
Beskrivning

Hepatitis, Autoimmune

Datatyp

boolean

Alias
UMLS CUI [1]
C0241910
alcoholic liver disease
Beskrivning

Alcoholic Liver Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023896
drug-related liver disease
Beskrivning

Drug-Induced Liver Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0860207
clinically significant laboratory abnormalities
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
uncontrolled clinically significant disease, disorder or medical illness
Beskrivning

Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318

Similar models

Eligibility Hepatitis C Virus NCT02023099

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
chronic hcv-infection prior to study enrollment
boolean
C0524910 (UMLS CUI [1])
Laboratory Results | Indication Hepatitis C Genotype
Item
screening laboratory result indicating hcv subgenotype 1b infection
boolean
C1254595 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1533728 (UMLS CUI [2,3])
Hepatitis C virus RNA assay Plasma
Item
subject has plasma hcv rna level greater than 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Informed Consent
Item
voluntarily sign an informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HBV coinfection | HIV coinfection | HCV coinfection Genotype | Exception Genotype
Item
co-infection of hepatitis b virus (hbv), hiv and any hcv genotype other than subgenotype 1b
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1533728 (UMLS CUI [4,2])
Prior Therapy Hepatitis C | DIRECT ACTING ANTIVIRALS | telaprevir | simeprevir | boceprevir
Item
prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir
boolean
C1514463 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C3653501 (UMLS CUI [2])
C1876229 (UMLS CUI [3])
C2605855 (UMLS CUI [4])
C1738934 (UMLS CUI [5])
Liver disease | Etiology Except Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv-infection, including but not limited to the following:
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Hemochromatosis
Item
hemochromatosis
boolean
C0018995 (UMLS CUI [1])
Alpha-1 Antitrypsin Deficiency
Item
alpha-1 antitrypsin deficiency
boolean
C0221757 (UMLS CUI [1])
Hepatolenticular Degeneration
Item
wilson's disease
boolean
C0019202 (UMLS CUI [1])
Hepatitis, Autoimmune
Item
autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Alcoholic Liver Disease
Item
alcoholic liver disease
boolean
C0023896 (UMLS CUI [1])
Drug-Induced Liver Disease
Item
drug-related liver disease
boolean
C0860207 (UMLS CUI [1])
Laboratory test result abnormal
Item
clinically significant laboratory abnormalities
boolean
C0438215 (UMLS CUI [1])
Disease Uncontrolled
Item
uncontrolled clinically significant disease, disorder or medical illness
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])

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