ID

34192

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01995071

Nyckelord

  1. 2019-01-15 2019-01-15 -
Rättsinnehavare

GSK group of companies

Uppladdad den

15 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Chronic Hepatitis C NCT01995071

Eligibility Chronic Hepatitis C NCT01995071

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

ID.1

Datatyp

boolean

screening laboratory result indicating hcv genotype 1-infection.
Beskrivning

ID.2

Datatyp

boolean

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

ID.3

Datatyp

boolean

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

ID.4

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

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

ID.5

Datatyp

boolean

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

ID.6

Datatyp

boolean

prior therapy for the treatment of hcv.
Beskrivning

ID.7

Datatyp

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.
Beskrivning

ID.8

Datatyp

boolean

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

ID.9

Datatyp

boolean

Similar models

Eligibility Chronic Hepatitis C NCT01995071

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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