ID

14911

Description

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02250807

Link

https://clinicaltrials.gov/show/NCT02250807

Keywords

Versions (1)
  1. 5/7/16 5/7/16 -
Uploaded on

May 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT02250807

English

Eligibility Chronic Hepatitis C NCT02250807

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with confirmed hepatitis c virus (hcv) with hcv rna greater than (>) 10000 international unit per milliliter (iu/ml)
Description

Hepatitis C virus | Hepatitis C virus RNA

Data type

boolean

Alias
UMLS CUI [1]
C0220847
UMLS CUI [2]
C0369335
subjects who are treatment naive or treatment-experienced.
Description

Therapy naive | Therapeutic procedure Experience

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0596545
subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
Description

Biopsy of liver | Transient elastography

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C2748260
subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, ct scan or magnetic resonance imaging [mri]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (hcc)
Description

Liver Cirrhosis | Diagnostic Imaging Hepatic | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0205054
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential
Description

Childbearing Potential | Contraceptive methods | Sexual Abstinence Heterosexuality | childbearing problem

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
UMLS CUI [3,1]
C0036899
UMLS CUI [3,2]
C0019421
UMLS CUI [4]
C1657137
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of clinical hepatic decompensation
Description

hepatic; decompensation

Data type

boolean

Alias
UMLS CUI [1]
C1394798
any liver disease of non-hcv etiology
Description

Liver diseases | Etiology aspects Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0220847
subjects with a past history of treatment with an approved or investigational daa
Description

Past Therapeutic procedure DIRECT ACTING ANTIVIRALS

Data type

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3653501
co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening)
Description

Coinfection HIV-1 | Coinfection Human immunodeficiency virus 2 (HIV-2) | Human Immunodeficiency Virus 1 (HIV-1) Antibodies Positive Laboratory Test Result | Human Immunodeficiency Virus 2 (HIV-2 ) Antibodies Positive Laboratory Test Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019704
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019707
UMLS CUI [3,1]
C1254603
UMLS CUI [3,2]
C1335447
UMLS CUI [4,1]
C1255639
UMLS CUI [4,2]
C1335447
infection/co-infection with hcv non-genotype 4
Description

Communicable Diseases Hepatitis C virus genotype 4 | Coinfection Hepatitis C virus genotype 4

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C3532922
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C3532922
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Similar models

Eligibility Chronic Hepatitis C NCT02250807

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus | Hepatitis C virus RNA
Item
subjects with confirmed hepatitis c virus (hcv) with hcv rna greater than (>) 10000 international unit per milliliter (iu/ml)
boolean
C0220847 (UMLS CUI [1])
C0369335 (UMLS CUI [2])
Therapy naive | Therapeutic procedure Experience
Item
subjects who are treatment naive or treatment-experienced.
boolean
C0919936 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0596545 (UMLS CUI [2,2])
Biopsy of liver | Transient elastography
Item
subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
boolean
C0193388 (UMLS CUI [1])
C2748260 (UMLS CUI [2])
Liver Cirrhosis | Diagnostic Imaging Hepatic | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, ct scan or magnetic resonance imaging [mri]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (hcc)
boolean
C0023890 (UMLS CUI [1])
C0011923 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C1456803 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Childbearing Potential | Contraceptive methods | Sexual Abstinence Heterosexuality | childbearing problem
Item
women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0036899 (UMLS CUI [3,1])
C0019421 (UMLS CUI [3,2])
C1657137 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
hepatic; decompensation
Item
evidence of clinical hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Liver diseases | Etiology aspects Hepatitis C virus
Item
any liver disease of non-hcv etiology
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
Past Therapeutic procedure DIRECT ACTING ANTIVIRALS
Item
subjects with a past history of treatment with an approved or investigational daa
boolean
C1444637 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3653501 (UMLS CUI [1,3])
Coinfection HIV-1 | Coinfection Human immunodeficiency virus 2 (HIV-2) | Human Immunodeficiency Virus 1 (HIV-1) Antibodies Positive Laboratory Test Result | Human Immunodeficiency Virus 2 (HIV-2 ) Antibodies Positive Laboratory Test Result
Item
co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening)
boolean
C0275524 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C1254603 (UMLS CUI [3,1])
C1335447 (UMLS CUI [3,2])
C1255639 (UMLS CUI [4,1])
C1335447 (UMLS CUI [4,2])
Communicable Diseases Hepatitis C virus genotype 4 | Coinfection Hepatitis C virus genotype 4
Item
infection/co-infection with hcv non-genotype 4
boolean
C0009450 (UMLS CUI [1,1])
C3532922 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C3532922 (UMLS CUI [2,2])
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