ID

36042

Description

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02023112

Link

https://clinicaltrials.gov/show/NCT02023112

Keywords

  1. 4/10/19 4/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 10, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C Virus NCT02023112

Eligibility Hepatitis C Virus NCT02023112

Inclusion Criteria
Description

Inclusion Criteria

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

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
screening laboratory result indicating hcv genotype 2 infection
Description

Laboratory Results Indication Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0019196
UMLS CUI [1,4]
C1285573
subject has plasma hcv rna level greater than 10,000 iu/ml at screening
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
voluntarily sign an informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection of hepatitis b virus (hbv), hiv and any hcv genotype other than genotype 2
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
UMLS CUI [3,1]
C1698259
UMLS CUI [3,2]
C0017431
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0017431
UMLS CUI [4,3]
C0205369
prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir
Description

DIRECT ACTING ANTIVIRALS Hepatitis C | telaprevir | simeprevir | boceprevir

Data type

boolean

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

Cause Liver disease | Exception Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
hemochromatosis
Description

Hemochromatosis

Data type

boolean

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

alpha 1-Antitrypsin Deficiency

Data type

boolean

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

Wilson's disease

Data type

boolean

Alias
UMLS CUI [1]
C0019202
autoimmune hepatitis
Description

Hepatitis, Autoimmune

Data type

boolean

Alias
UMLS CUI [1]
C0241910
alcoholic liver disease
Description

Alcoholic Liver Disease

Data type

boolean

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

Drug-Induced Liver Disease

Data type

boolean

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

Laboratory test result abnormal

Data type

boolean

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

Disease Uncontrolled | Illness Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205318

Similar models

Eligibility Hepatitis C Virus NCT02023112

Name
Type
Description | Question | Decode (Coded Value)
Data type
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 genotype 2 infection
boolean
C1254595 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C1285573 (UMLS CUI [1,4])
Hepatitis C virus RNA assay
Item
subject has plasma hcv rna level greater than 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
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 Specified
Item
co-infection of hepatitis b virus (hbv), hiv and any hcv genotype other than genotype 2
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3,1])
C0017431 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0017431 (UMLS CUI [4,2])
C0205369 (UMLS CUI [4,3])
DIRECT ACTING ANTIVIRALS Hepatitis C | telaprevir | simeprevir | boceprevir
Item
prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir
boolean
C3653501 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C1876229 (UMLS CUI [2])
C2605855 (UMLS CUI [3])
C1738934 (UMLS CUI [4])
Cause Liver disease | Exception Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv-infection, including but not limited to the following:
boolean
C0015127 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Hemochromatosis
Item
hemochromatosis
boolean
C0018995 (UMLS CUI [1])
alpha 1-Antitrypsin Deficiency
Item
alpha-1 antitrypsin deficiency
boolean
C0221757 (UMLS CUI [1])
Wilson's disease
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 | Illness Uncontrolled
Item
uncontrolled clinically significant disease, disorder or medical illness
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])

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