ID

34192

Beschrijving

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

Trefwoorden

  1. 15-01-19 15-01-19 -
Houder van rechten

GSK group of companies

Geüploaded op

15 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Chronic Hepatitis C NCT01995071

Eligibility Chronic Hepatitis C NCT01995071

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

ID.1

Datatype

boolean

screening laboratory result indicating hcv genotype 1-infection.
Beschrijving

ID.2

Datatype

boolean

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

ID.3

Datatype

boolean

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

ID.4

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

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

ID.5

Datatype

boolean

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

ID.6

Datatype

boolean

prior therapy for the treatment of hcv.
Beschrijving

ID.7

Datatype

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.
Beschrijving

ID.8

Datatype

boolean

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

ID.9

Datatype

boolean

Similar models

Eligibility Chronic Hepatitis C NCT01995071

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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

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