ID

33488

Beskrivning

A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults; ODM derived from: https://clinicaltrials.gov/show/NCT01715415

Länk

https://clinicaltrials.gov/show/NCT01715415

Nyckelord

  1. 2018-12-11 2018-12-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 december 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis C Infection NCT01715415

Eligibility Chronic Hepatitis C Infection NCT01715415

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
Beskrivning

Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
chronic hepatitis c, genotype 1 infection and hcv rna level greater than 10,000 iu/ml at screening.
Beskrivning

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
UMLS CUI [2]
C1272251
previous treatment failure of peg-interferon and ribavirin (pegifn and rbv).
Beskrivning

Peginterferon failed | Ribavirin failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C0231175
no evidence of liver cirrhosis.
Beskrivning

Liver Cirrhosis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive screen for drugs or alcohol.
Beskrivning

Alcohol and/or drug screening Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1743165
UMLS CUI [1,2]
C1514241
significant sensitivity to any drug.
Beskrivning

Drug Allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
use of contraindicated medications within 2 weeks of dosing.
Beskrivning

Medication contraindicated

Datatyp

boolean

Alias
UMLS CUI [1]
C3468957
certain predefined abnormal laboratory tests.
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
positive hepatitis b surface antigen or anti-human immunodeficiency virus antibody.
Beskrivning

Hepatitis B surface antigen positive | HIV antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548

Similar models

Eligibility Chronic Hepatitis C Infection NCT01715415

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Female Sterilization | Gender Contraceptive methods
Item
females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
chronic hepatitis c, genotype 1 infection and hcv rna level greater than 10,000 iu/ml at screening.
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Peginterferon failed | Ribavirin failed
Item
previous treatment failure of peg-interferon and ribavirin (pegifn and rbv).
boolean
C0982327 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Liver Cirrhosis Absent
Item
no evidence of liver cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Alcohol and/or drug screening Positive
Item
positive screen for drugs or alcohol.
boolean
C1743165 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Drug Allergy
Item
significant sensitivity to any drug.
boolean
C0013182 (UMLS CUI [1])
Medication contraindicated
Item
use of contraindicated medications within 2 weeks of dosing.
boolean
C3468957 (UMLS CUI [1])
Laboratory test result abnormal
Item
certain predefined abnormal laboratory tests.
boolean
C0438215 (UMLS CUI [1])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive hepatitis b surface antigen or anti-human immunodeficiency virus antibody.
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])

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