ID

34326

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01125189

Trefwoorden

  1. 16-01-19 16-01-19 -
Houder van rechten

see on clinicaltrials.gov

Geüploaded op

16 januari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatitis C Virus NCT01125189

Eligibility Hepatitis C Virus NCT01125189

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

ID.1

Datatype

boolean

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

ID.2

Datatype

boolean

no previous exposure to interferon, pegifnα, or rbv
Beschrijving

ID.3

Datatype

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)
Beschrijving

ID.4

Datatype

boolean

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

ID.5

Datatype

boolean

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

ID.6

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

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

ID.7

Datatype

boolean

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

ID.8

Datatype

boolean

evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Beschrijving

ID.9

Datatype

boolean

Similar models

Eligibility Hepatitis C Virus NCT01125189

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

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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