ID

34192

Description

A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV); ODM derived from: https://clinicaltrials.gov/show/NCT01995071

Link

https://clinicaltrials.gov/show/NCT01995071

Keywords

  1. 1/15/19 1/15/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 15, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Chronic Hepatitis C NCT01995071

Eligibility Chronic Hepatitis C NCT01995071

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv infection prior to study enrollment.
Description

ID.1

Data type

boolean

screening laboratory result indicating hcv genotype 1-infection.
Description

ID.2

Data type

boolean

subject has plasma hcv rna level greater than 10,000 iu/ml at screening.
Description

ID.3

Data type

boolean

per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe, life-threatening or other significant sensitivity to any drug.
Description

ID.5

Data type

boolean

positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
Description

ID.6

Data type

boolean

prior therapy for the treatment of hcv.
Description

ID.7

Data type

boolean

any current or past clinical evidence of child pugh b or c classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
Description

ID.8

Data type

boolean

any cause of liver disease other than chronic hcv infection.
Description

ID.9

Data type

boolean

Similar models

Eligibility Chronic Hepatitis C NCT01995071

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
chronic hcv infection prior to study enrollment.
boolean
ID.2
Item
screening laboratory result indicating hcv genotype 1-infection.
boolean
ID.3
Item
subject has plasma hcv rna level greater than 10,000 iu/ml at screening.
boolean
ID.4
Item
per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
history of severe, life-threatening or other significant sensitivity to any drug.
boolean
ID.6
Item
positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
boolean
ID.7
Item
prior therapy for the treatment of hcv.
boolean
ID.8
Item
any current or past clinical evidence of child pugh b or c classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
boolean
ID.9
Item
any cause of liver disease other than chronic hcv infection.
boolean

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial