ID

34326

Description

Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01125189

Link

https://clinicaltrials.gov/show/NCT01125189

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C Virus NCT01125189

Eligibility Hepatitis C Virus NCT01125189

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv genotype 1 or 4
Description

ID.1

Data type

boolean

hcv rna viral load of ≥ 100,000 iu/ml
Description

ID.2

Data type

boolean

no previous exposure to interferon, pegifnα, or rbv
Description

ID.3

Data type

boolean

results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. compensated cirrhotics with hcv genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
Description

ID.4

Data type

boolean

ultrasound, ct scan, or mri results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
Description

ID.5

Data type

boolean

body mass index (bmi) of 18 to 35 kg/m²
Description

ID.6

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive for hepatitis b or hiv-1/hiv-2 antibody at screening
Description

ID.7

Data type

boolean

evidence of a medical condition associated with chronic liver disease other than hcv
Description

ID.8

Data type

boolean

evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Description

ID.9

Data type

boolean

Similar models

Eligibility Hepatitis C Virus NCT01125189

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
subjects chronically infected with hcv genotype 1 or 4
boolean
ID.2
Item
hcv rna viral load of ≥ 100,000 iu/ml
boolean
ID.3
Item
no previous exposure to interferon, pegifnα, or rbv
boolean
ID.4
Item
results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. compensated cirrhotics with hcv genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
boolean
ID.5
Item
ultrasound, ct scan, or mri results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
boolean
ID.6
Item
body mass index (bmi) of 18 to 35 kg/m²
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
positive for hepatitis b or hiv-1/hiv-2 antibody at screening
boolean
ID.8
Item
evidence of a medical condition associated with chronic liver disease other than hcv
boolean
ID.9
Item
evidence of decompensated cirrhosis based on radiologic criteria or biopsy
boolean

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