ID

34326

Description

Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01125189

Lien

https://clinicaltrials.gov/show/NCT01125189

Mots-clés

Versions (1)
  1. 16/01/2019 16/01/2019 -
Détendeur de droits

see on clinicaltrials.gov

Téléchargé le

16 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Hepatitis C Virus NCT01125189

Anglais

Eligibility Hepatitis C Virus NCT01125189

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv genotype 1 or 4
Description

ID.1

Type de données

boolean

hcv rna viral load of ≥ 100,000 iu/ml
Description

ID.2

Type de données

boolean

no previous exposure to interferon, pegifnα, or rbv
Description

ID.3

Type de données

boolean

results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. compensated cirrhotics with hcv genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
Description

ID.4

Type de données

boolean

ultrasound, ct scan, or mri results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
Description

ID.5

Type de données

boolean

body mass index (bmi) of 18 to 35 kg/m²
Description

ID.6

Type de données

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive for hepatitis b or hiv-1/hiv-2 antibody at screening
Description

ID.7

Type de données

boolean

evidence of a medical condition associated with chronic liver disease other than hcv
Description

ID.8

Type de données

boolean

evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Description

ID.9

Type de données

boolean

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Similar models

Eligibility Hepatitis C Virus NCT01125189

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
subjects chronically infected with hcv genotype 1 or 4
boolean
ID.2
Item
hcv rna viral load of ≥ 100,000 iu/ml
boolean
ID.3
Item
no previous exposure to interferon, pegifnα, or rbv
boolean
ID.4
Item
results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. compensated cirrhotics with hcv genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
boolean
ID.5
Item
ultrasound, ct scan, or mri results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
boolean
ID.6
Item
body mass index (bmi) of 18 to 35 kg/m²
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
positive for hepatitis b or hiv-1/hiv-2 antibody at screening
boolean
ID.8
Item
evidence of a medical condition associated with chronic liver disease other than hcv
boolean
ID.9
Item
evidence of decompensated cirrhosis based on radiologic criteria or biopsy
boolean
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