ID

39648

Description

Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation; ODM derived from: https://clinicaltrials.gov/show/NCT01687257

Link

https://clinicaltrials.gov/show/NCT01687257

Keywords

Versions (1)
  1. 2/8/20 2/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 8, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01687257

English

Eligibility Hepatitis C NCT01687257

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic infection with hepatitis c with hcv rna > 1000 iu/ml
Description

Hepatitis C, Chronic | Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C1272251
individuals with cirrhosis with child-pugh score < 10
Description

Liver Cirrhosis | Child-Pugh - Total Score

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C4055253
esophageal or gastric varices on endoscopy within 6 months prior to or at screening
Description

Esophageal Varices Endoscopy | Gastric Varices Endoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0014867
UMLS CUI [1,2]
C0014245
UMLS CUI [2,1]
C0017145
UMLS CUI [2,2]
C0014245
hepatic venous pressure gradient (hvpg) > 6 mmhg
Description

Hepatic venous pressure gradient

Data type

boolean

Alias
UMLS CUI [1]
C4049263
body mass index (bmi) ≥ 18 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
naïve to all nucleotides/nucleoside treatments for chronic hcv infection
Description

Nucleotides Absent Chronic Hepatitis C | Nucleosides Absent Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0028630
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0524910
UMLS CUI [2,1]
C0028621
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0524910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
Description

Illness Serious Interferes with Therapeutic procedure | Illness Interferes with Therapeutic procedure | Serious mental illness Interferes with Therapeutic procedure | Mental disorder Interferes with Therapeutic procedure | Illness Serious Interferes with Assessment | Illness Interferes with Assessment | Serious mental illness Interferes with Assessment | Mental disorder Interferes with Assessment | Illness Serious Interferes with Compliance | Illness Interferes with Compliance | Serious mental illness Interferes with Compliance | Mental disorder Interferes with Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C3841614
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0087111
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C1516048
UMLS CUI [6,1]
C0221423
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1516048
UMLS CUI [7,1]
C3841614
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C1516048
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C1516048
UMLS CUI [9,1]
C0221423
UMLS CUI [9,2]
C0205404
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C1321605
UMLS CUI [10,1]
C0221423
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C1321605
UMLS CUI [11,1]
C3841614
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C1321605
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C1321605
hiv or chronic hepatitis b virus (hbv) infection (hbsag positive)
Description

HIV Infection | Hepatitis B, Chronic | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0149709
alpha-fetoprotein (afp) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
Description

Alpha one fetoprotein measurement | Exception Liver mass Imaging Negative

Data type

boolean

Alias
UMLS CUI [1]
C0201539
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0240225
UMLS CUI [2,3]
C0011923
UMLS CUI [2,4]
C1513916
refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening
Description

Refractory ascites | Requirement Paracentesis times per month

Data type

boolean

Alias
UMLS CUI [1]
C3532188
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0034115
UMLS CUI [2,3]
C0556969
active variceal bleeding within 6 months of screening
Description

Bleeding varices

Data type

boolean

Alias
UMLS CUI [1]
C0333106
expected survival of < 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
history of hepatorenal, or hepatopulmonary syndrome.
Description

Hepatorenal Syndrome | Hepatopulmonary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0019212
UMLS CUI [2]
C0600452
evidence of renal impairment (crcl < 50 ml/min)
Description

Renal Insufficiency | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0373595
history of major organ transplantation, including liver transplant.
Description

Transplantation Organ Major | Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205164
UMLS CUI [2]
C0023911
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Similar models

Eligibility Hepatitis C NCT01687257

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C virus RNA assay
Item
chronic infection with hepatitis c with hcv rna > 1000 iu/ml
boolean
C0524910 (UMLS CUI [1])
C1272251 (UMLS CUI [2])
Liver Cirrhosis | Child-Pugh - Total Score
Item
individuals with cirrhosis with child-pugh score < 10
boolean
C0023890 (UMLS CUI [1])
C4055253 (UMLS CUI [2])
Esophageal Varices Endoscopy | Gastric Varices Endoscopy
Item
esophageal or gastric varices on endoscopy within 6 months prior to or at screening
boolean
C0014867 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
C0017145 (UMLS CUI [2,1])
C0014245 (UMLS CUI [2,2])
Hepatic venous pressure gradient
Item
hepatic venous pressure gradient (hvpg) > 6 mmhg
boolean
C4049263 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≥ 18 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Nucleotides Absent Chronic Hepatitis C | Nucleosides Absent Chronic Hepatitis C
Item
naïve to all nucleotides/nucleoside treatments for chronic hcv infection
boolean
C0028630 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0028621 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Illness Serious Interferes with Therapeutic procedure | Illness Interferes with Therapeutic procedure | Serious mental illness Interferes with Therapeutic procedure | Mental disorder Interferes with Therapeutic procedure | Illness Serious Interferes with Assessment | Illness Interferes with Assessment | Serious mental illness Interferes with Assessment | Mental disorder Interferes with Assessment | Illness Serious Interferes with Compliance | Illness Interferes with Compliance | Serious mental illness Interferes with Compliance | Mental disorder Interferes with Compliance
Item
have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C3841614 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0221423 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C1516048 (UMLS CUI [5,4])
C0221423 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1516048 (UMLS CUI [6,3])
C3841614 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1516048 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1516048 (UMLS CUI [8,3])
C0221423 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C1321605 (UMLS CUI [9,4])
C0221423 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C1321605 (UMLS CUI [10,3])
C3841614 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C1321605 (UMLS CUI [11,3])
C0004936 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C1321605 (UMLS CUI [12,3])
HIV Infection | Hepatitis B, Chronic | Hepatitis B surface antigen positive
Item
hiv or chronic hepatitis b virus (hbv) infection (hbsag positive)
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Alpha one fetoprotein measurement | Exception Liver mass Imaging Negative
Item
alpha-fetoprotein (afp) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
boolean
C0201539 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0240225 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C1513916 (UMLS CUI [2,4])
Refractory ascites | Requirement Paracentesis times per month
Item
refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening
boolean
C3532188 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0034115 (UMLS CUI [2,2])
C0556969 (UMLS CUI [2,3])
Bleeding varices
Item
active variceal bleeding within 6 months of screening
boolean
C0333106 (UMLS CUI [1])
Life Expectancy
Item
expected survival of < 1 year
boolean
C0023671 (UMLS CUI [1])
Hepatorenal Syndrome | Hepatopulmonary Syndrome
Item
history of hepatorenal, or hepatopulmonary syndrome.
boolean
C0019212 (UMLS CUI [1])
C0600452 (UMLS CUI [2])
Renal Insufficiency | Creatinine clearance measurement
Item
evidence of renal impairment (crcl < 50 ml/min)
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Transplantation Organ Major | Transplantation of liver
Item
history of major organ transplantation, including liver transplant.
boolean
C0040732 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0023911 (UMLS CUI [2])
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