ID

36038

Beskrivning

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02496078

Länk

https://clinicaltrials.gov/show/NCT02496078

Nyckelord

Versioner (1)
  1. 2019-04-10 2019-04-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02496078

Engelsk

Eligibility Hepatitis C NCT02496078

1 Formulär  
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients chronically infected with hcv genotype 1b
Beskrivning

Chronic Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
no previous exposure to any interferon formulation, ribavirin (rbv), and hcv direct acting antiviral agent
Beskrivning

Absence Exposure to Interferon Formulation | Absence Exposure to Ribavirin | Absence Exposure to HCV DIRECT ACTING ANTIVIRALS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C3652465
UMLS CUI [1,4]
C0524527
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C0220847
UMLS CUI [3,4]
C3653501
hcv rna viral load ≥ 10,000 iu/ml at screening
Beskrivning

Hepatitis C virus RNA assay

Datatyp

boolean

Alias
UMLS CUI [1]
C1272251
seronegative for hiv and hbsag
Beskrivning

HIV Seronegative | Hepatitis B Surface Antigens Seronegative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521144
bmi of 18-35 kg/m2, inclusive
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
patients with compensated cirrhosis are permitted
Beskrivning

Compensated cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C1608426
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
infection with hcv other than genotype (gt) -1b
Beskrivning

Hepatitis C | Exception Genotype Specified

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017431
UMLS CUI [2,3]
C0205369
evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Beskrivning

Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
evidence of a medical condition contributing to chronic liver disease other than hcv
Beskrivning

Medical condition Contributing Chronic liver disease | Exception HCV

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220847
diagnosed or suspected hepatocellular carcinoma or other malignancies
Beskrivning

Liver carcinoma | Liver carcinoma Suspected | Cancer Other | Cancer Other Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C1707251
UMLS CUI [4,1]
C1707251
UMLS CUI [4,2]
C0750491
uncontrolled diabetes or hypertension
Beskrivning

Diabetic - poor control | Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C1868885
history of moderate to severe depression. well-controlled mild depression is allowed
Beskrivning

Moderate depression | Severe depression | Mild depression Well controlled allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0588007
UMLS CUI [2]
C0588008
UMLS CUI [3,1]
C0588006
UMLS CUI [3,2]
C3853142
UMLS CUI [3,3]
C0683607
confirmed alanine aminotransferase (alt) ≥ 5x upper limit of normal (uln)
Beskrivning

Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
confirmed platelet count < 50,000 cells/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
confirmed hemoglobin < 8.5 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
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Similar models

Eligibility Hepatitis C NCT02496078

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
patients chronically infected with hcv genotype 1b
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Absence Exposure to Interferon Formulation | Absence Exposure to Ribavirin | Absence Exposure to HCV DIRECT ACTING ANTIVIRALS
Item
no previous exposure to any interferon formulation, ribavirin (rbv), and hcv direct acting antiviral agent
boolean
C0332197 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C3652465 (UMLS CUI [1,3])
C0524527 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0220847 (UMLS CUI [3,3])
C3653501 (UMLS CUI [3,4])
Hepatitis C virus RNA assay
Item
hcv rna viral load ≥ 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
HIV Seronegative | Hepatitis B Surface Antigens Seronegative
Item
seronegative for hiv and hbsag
boolean
C0019682 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
Body mass index
Item
bmi of 18-35 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Compensated cirrhosis
Item
patients with compensated cirrhosis are permitted
boolean
C1608426 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis C | Exception Genotype Specified
Item
infection with hcv other than genotype (gt) -1b
boolean
C0019196 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
boolean
C0745744 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Medical condition Contributing Chronic liver disease | Exception HCV
Item
evidence of a medical condition contributing to chronic liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
Liver carcinoma | Liver carcinoma Suspected | Cancer Other | Cancer Other Suspected
Item
diagnosed or suspected hepatocellular carcinoma or other malignancies
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1707251 (UMLS CUI [3])
C1707251 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Diabetic - poor control | Uncontrolled hypertension
Item
uncontrolled diabetes or hypertension
boolean
C0421258 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
Moderate depression | Severe depression | Mild depression Well controlled allowed
Item
history of moderate to severe depression. well-controlled mild depression is allowed
boolean
C0588007 (UMLS CUI [1])
C0588008 (UMLS CUI [2])
C0588006 (UMLS CUI [3,1])
C3853142 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Alanine aminotransferase increased
Item
confirmed alanine aminotransferase (alt) ≥ 5x upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
Platelet Count measurement
Item
confirmed platelet count < 50,000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
confirmed hemoglobin < 8.5 g/dl
boolean
C0518015 (UMLS CUI [1])
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