ID

35885

Description

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02487199

Link

https://clinicaltrials.gov/show/NCT02487199

Keywords

Versions (1)
  1. 4/1/19 4/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility HCV NCT02487199

English

Eligibility HCV NCT02487199

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility HCV NCT02487199
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, genotype 1a infection or genotype 4 infection (hcv rna level greater than 1,000 iu/ml at screening).
Description

Hepatitis C, Chronic | Hepatitis C virus genotype Infection | Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C1148363
UMLS CUI [2,2]
C0009450
UMLS CUI [3]
C1272251
females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
Description

Postmenopausal state | Childbearing Potential Absent | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
chronic kidney disease stage 4 or stage 5.
Description

Chronic Kidney Disease Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody
Description

Hepatitis B surface antigen positive | HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
hcv genotype performed during screening unable to genotype or co-infection with any other hcv genotype, no mixed genotypes.
Description

Hepatitis C virus genotype determination | Genotype Mixed Absent

Data type

boolean

Alias
UMLS CUI [1]
C1533728
UMLS CUI [2,1]
C0017431
UMLS CUI [2,2]
C0205430
UMLS CUI [2,3]
C0332197
abnormal laboratory tests
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
current enrollment in another investigational study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
previous or current treatment with a direct acting antiviral agent (daa) containing regimen
Description

DIRECT ACTING ANTIVIRALS

Data type

boolean

Alias
UMLS CUI [1]
C3653501
any evidence of liver cirrhosis or liver cancer
Description

Liver Cirrhosis | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C2239176
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Similar models

Eligibility HCV NCT02487199

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility HCV NCT02487199
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C virus genotype Infection | Hepatitis C virus RNA assay
Item
chronic hepatitis c, genotype 1a infection or genotype 4 infection (hcv rna level greater than 1,000 iu/ml at screening).
boolean
C0524910 (UMLS CUI [1])
C1148363 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3])
Postmenopausal state | Childbearing Potential Absent | Childbearing Potential Contraceptive methods
Item
females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
boolean
C0232970 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Chronic Kidney Disease Stage
Item
chronic kidney disease stage 4 or stage 5.
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Hepatitis C virus genotype determination | Genotype Mixed Absent
Item
hcv genotype performed during screening unable to genotype or co-infection with any other hcv genotype, no mixed genotypes.
boolean
C1533728 (UMLS CUI [1])
C0017431 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Laboratory test result abnormal
Item
abnormal laboratory tests
boolean
C0438215 (UMLS CUI [1])
Study Subject Participation Status
Item
current enrollment in another investigational study
boolean
C2348568 (UMLS CUI [1])
DIRECT ACTING ANTIVIRALS
Item
previous or current treatment with a direct acting antiviral agent (daa) containing regimen
boolean
C3653501 (UMLS CUI [1])
Liver Cirrhosis | Liver carcinoma
Item
any evidence of liver cirrhosis or liver cancer
boolean
C0023890 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
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