ID

39681

Description

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01672983

Link

https://clinicaltrials.gov/show/NCT01672983

Keywords

  1. 2/9/20 2/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C Virus NCT01672983

Eligibility Hepatitis C Virus NCT01672983

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously received pegylated interferon alpha-2a/ribavirin.
Description

Peginterferon alfa-2a plus Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0391001
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0035525
chronic hepatitis c virus infection.
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
plasma hepatitis c virus ribonucleic acid level greater than 10,000 international units/milliliter.
Description

Hepatitis C virus RNA assay Plasma

Data type

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
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
history of severe, life-threatening sensitivity to any drug.
Description

Drug Allergy Severe Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2826244
females who are pregnant or plan to become pregnant, or breastfeeding.
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
recent history of drug or alcohol abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
positive test result for hepatitis b surface antigen or anti-human immunodeficiency virus antibodies.
Description

Hepatitis B surface antigen positive | HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
any current or past clinical evidence of cirrhosis.
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
previous use of any investigational or commercially available anti-hepatitis c virus agent other than pegylated interferon alpha-2a and ribavirin, including previous exposure to abt-450 or abt-267.
Description

Anti-hepatitis C (HCV) Agents | Exception Peginterferon alfa-2a | Exception Ribavirin | ABT-450 | ABT-267

Data type

boolean

Alias
UMLS CUI [1]
C4324240
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0391001
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0035525
UMLS CUI [4]
C3712108
UMLS CUI [5]
C3713322

Similar models

Eligibility Hepatitis C Virus NCT01672983

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Peginterferon alfa-2a plus Ribavirin
Item
previously received pegylated interferon alpha-2a/ribavirin.
boolean
C0391001 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
Hepatitis C, Chronic
Item
chronic hepatitis c virus infection.
boolean
C0524910 (UMLS CUI [1])
Hepatitis C virus RNA assay Plasma
Item
plasma hepatitis c virus ribonucleic acid level greater than 10,000 international units/milliliter.
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)
Drug Allergy Severe Life Threatening
Item
history of severe, life-threatening sensitivity to any drug.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
females who are pregnant or plan to become pregnant, or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Substance Use Disorders
Item
recent history of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result for hepatitis b surface antigen or anti-human immunodeficiency virus antibodies.
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Liver Cirrhosis
Item
any current or past clinical evidence of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Anti-hepatitis C (HCV) Agents | Exception Peginterferon alfa-2a | Exception Ribavirin | ABT-450 | ABT-267
Item
previous use of any investigational or commercially available anti-hepatitis c virus agent other than pegylated interferon alpha-2a and ribavirin, including previous exposure to abt-450 or abt-267.
boolean
C4324240 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0391001 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C3712108 (UMLS CUI [4])
C3713322 (UMLS CUI [5])

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