ID

40911

Description

Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives); ODM derived from: https://clinicaltrials.gov/show/NCT01581203

Link

https://clinicaltrials.gov/show/NCT01581203

Keywords

Versions (1)
  1. 6/3/20 6/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 3, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01581203

English

Eligibility Hepatitis C Virus NCT01581203

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hcv genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, or intolerant or ineligible to p/r due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, or treatment naive
Description

Hepatitis C Genotype | Prior Therapy failed | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Therapy non-responder | Partial responder to therapy | Intolerance to PEGINTERFERON/RIBAVIRIN | Ineligibility PEGINTERFERON/RIBAVIRIN | Neutropenia | Anemia | Depressive disorder | Thrombocytopenia | Fibrosis | Liver Cirrhosis | Therapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0391001
UMLS CUI [4]
C0796545
UMLS CUI [5]
C0035525
UMLS CUI [6]
C0919875
UMLS CUI [7]
C1740822
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C1875630
UMLS CUI [9,1]
C1512714
UMLS CUI [9,2]
C1875630
UMLS CUI [10]
C0027947
UMLS CUI [11]
C0002871
UMLS CUI [12]
C0011581
UMLS CUI [13]
C0040034
UMLS CUI [14]
C0016059
UMLS CUI [15]
C0023890
UMLS CUI [16]
C0919936
hcv rna ≥ 10,000 iu/ml
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag)
Description

HIV Seronegative | Hepatitis B Surface Antigens Seronegative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521144
subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
Description

Compensated cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C1608426
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment of hcv with hcv direct acting antiviral (daa)
Description

Prior Therapy Hepatitis C | HCV DIRECT ACTING ANTIVIRALS

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C3653501
evidence of a medical condition contributing to chronic liver disease other than hcv
Description

Medical condition Contributing Chronic liver disease | Exception Hepatitis C

Data type

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]
C0019196
evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Description

End Stage Liver Disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
diagnosed or suspected hepatocellular carcinoma or other malignancies
Description

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

Data type

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
Description

Diabetic - poor control | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C1868885
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Similar models

Eligibility Hepatitis C Virus NCT01581203

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females, ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis C Genotype | Prior Therapy failed | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Therapy non-responder | Partial responder to therapy | Intolerance to PEGINTERFERON/RIBAVIRIN | Ineligibility PEGINTERFERON/RIBAVIRIN | Neutropenia | Anemia | Depressive disorder | Thrombocytopenia | Fibrosis | Liver Cirrhosis | Therapy naive
Item
hcv genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, or intolerant or ineligible to p/r due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, or treatment naive
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0391001 (UMLS CUI [3])
C0796545 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C0919875 (UMLS CUI [6])
C1740822 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C1875630 (UMLS CUI [8,2])
C1512714 (UMLS CUI [9,1])
C1875630 (UMLS CUI [9,2])
C0027947 (UMLS CUI [10])
C0002871 (UMLS CUI [11])
C0011581 (UMLS CUI [12])
C0040034 (UMLS CUI [13])
C0016059 (UMLS CUI [14])
C0023890 (UMLS CUI [15])
C0919936 (UMLS CUI [16])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
HIV Seronegative | Hepatitis B Surface Antigens Seronegative
Item
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag)
boolean
C0019682 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
Compensated cirrhosis
Item
subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
boolean
C1608426 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Hepatitis C | HCV DIRECT ACTING ANTIVIRALS
Item
prior treatment of hcv with hcv direct acting antiviral (daa)
boolean
C1514463 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0220847 (UMLS CUI [2,1])
C3653501 (UMLS CUI [2,2])
Medical condition Contributing Chronic liver disease | Exception Hepatitis C
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])
C0019196 (UMLS CUI [2,2])
End Stage 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])
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])
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