ID

34192

Descrição

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

Palavras-chave

  1. 15/01/2019 15/01/2019 -
Titular dos direitos

GSK group of companies

Transferido a

15 de janeiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility Chronic Hepatitis C NCT01995071

Eligibility Chronic Hepatitis C NCT01995071

Inclusion Criteria
Descrição

Inclusion Criteria

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

ID.1

Tipo de dados

boolean

screening laboratory result indicating hcv genotype 1-infection.
Descrição

ID.2

Tipo de dados

boolean

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

ID.3

Tipo de dados

boolean

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

ID.4

Tipo de dados

boolean

Exclusion Criteria
Descrição

Exclusion Criteria

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

ID.5

Tipo de dados

boolean

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

ID.6

Tipo de dados

boolean

prior therapy for the treatment of hcv.
Descrição

ID.7

Tipo de dados

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.
Descrição

ID.8

Tipo de dados

boolean

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

ID.9

Tipo de dados

boolean

Similar models

Eligibility Chronic Hepatitis C NCT01995071

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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