ID

34325

Description

Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01754974

Link

https://clinicaltrials.gov/show/NCT01754974

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 (HCV) NCT01754974

Eligibility Hepatitis C Virus (HCV) NCT01754974

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, genotype 1
Description

ID.1

Data type

boolean

hcv rna ≥100,000 iu/ml at screening
Description

ID.2

Data type

boolean

liver biopsy documenting no cirrhosis (within prior 3 years). where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
Description

ID.3

Data type

boolean

naïve to prior anti-hcv therapy
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
infected with hcv other than genotype 1
Description

ID.5

Data type

boolean

positive hepatitis b surface antigen (hbsag), or human immunodeficiency virus (hiv)-1/hiv-2 antibody at screening
Description

ID.6

Data type

boolean

evidence of liver disease other than hcv
Description

ID.7

Data type

boolean

active substance abuse
Description

ID.8

Data type

boolean

use of hematologic growth factors within 90 days prior to study randomization
Description

ID.9

Data type

boolean

evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Description

ID.10

Data type

boolean

Similar models

Eligibility Hepatitis C Virus (HCV) NCT01754974

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
chronic hepatitis c, genotype 1
boolean
ID.2
Item
hcv rna ≥100,000 iu/ml at screening
boolean
ID.3
Item
liver biopsy documenting no cirrhosis (within prior 3 years). where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
boolean
ID.4
Item
naïve to prior anti-hcv therapy
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
infected with hcv other than genotype 1
boolean
ID.6
Item
positive hepatitis b surface antigen (hbsag), or human immunodeficiency virus (hiv)-1/hiv-2 antibody at screening
boolean
ID.7
Item
evidence of liver disease other than hcv
boolean
ID.8
Item
active substance abuse
boolean
ID.9
Item
use of hematologic growth factors within 90 days prior to study randomization
boolean
ID.10
Item
evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria
boolean

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