ID

29735

Beskrivning

Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00565539

Länk

https://clinicaltrials.gov/show/NCT00565539

Nyckelord

Versioner (1)
  1. 2018-04-16 2018-04-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00565539

Engelsk

Eligibility Hepatitis C, Chronic NCT00565539

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed subjects (parts 1 and 2) -- prior treatment for hcv with peg-ifn-alpha (or other ifn-alpha) and ribavirin for at least 12 weeks. naive subjects (part 3) -- no prior treatment with peg-ifn-alpha (or other ifn-alpha)
Beskrivning

Recurrent disease | Prior Therapy Hepatitis C virus | peginterferon alfa-2a | peginterferon alfa-2b | Interferon-alpha | Ribavirin | Therapy naive

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0220847
UMLS CUI [3]
C0391001
UMLS CUI [4]
C0796545
UMLS CUI [5]
C0002199
UMLS CUI [6]
C0035525
UMLS CUI [7]
C0919936
genotype 1 hcv rna greater than or equal to 100,000 iu/ml. mixed genotype hcv infection is not allowed
Beskrivning

Hepatitis C virus RNA assay HCV genotype determination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C1533728
documented liver biopsy ≤2 years of study enrollment with ishak score ≤4
Beskrivning

Biopsy of liver Ishak Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C2986945
no evidence of hepatocellular carcinoma documented by abdominal imaging within 12 months of study entry
Beskrivning

Absence Liver carcinoma Imaging of abdomen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C2711454
no evidence of clinically significant diastolic or systolic dysfunction or other clinically significant abnormalities on echocardiogram or ecg
Beskrivning

Diastolic dysfunction Absent | Systolic dysfunction Absent | Echocardiogram normal | ECG normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0520863
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0749225
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0436484
UMLS CUI [4]
C0522054
negative drug and alcohol tests except for physician prescribed or approved medication
Beskrivning

Drug abuse test Negative | Alcohol use test Negative | Exception Drug Prescriptions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451130
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0679532
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0033081
if male, or female of child-bearing potential, agrees to use 2 forms of medically accepted contraception while on study
Beskrivning

Gender Contraceptive methods Quantity | Childbearing Potential Contraceptive methods Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of decompensated liver disease
Beskrivning

Decompensated liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C4075847
history of hypersensitivity to ifn-alpha or ribavirin
Beskrivning

Hypersensitivity Interferon-alpha | Hypersensitivity Ribavirin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002199
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0035525
active substance abuse, such as alcohol, inhaled or injection drugs within the previous 6 months
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
undergone surgery or received blood products within 30 days prior to study enrollment
Beskrivning

Operative Surgical Procedures | Blood product Received

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C1514756
prior history of cardiomyopathy, coronary artery disease including angina, interventive procedure for coronary artery disease including angioplasty, stent procedure or cardiac bypass surgery, prior myocardial infarction, or ventricular tachycardia
Beskrivning

Cardiomyopathy | Coronary Artery Disease | Angina Pectoris | Interventional procedure Coronary Artery Disease | Angioplasty | Placement of stent | Coronary Artery Bypass Surgery | Myocardial Infarction | Tachycardia, Ventricular

Datatyp

boolean

Alias
UMLS CUI [1]
C0878544
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0002962
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C1956346
UMLS CUI [5]
C0162577
UMLS CUI [6]
C0522776
UMLS CUI [7]
C0010055
UMLS CUI [8]
C0027051
UMLS CUI [9]
C0042514
prior or current history of hemoglobinopathy or hemolytic anemia
Beskrivning

Hemoglobinopathy | Anemia, Hemolytic

Datatyp

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0002878
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Similar models

Eligibility Hepatitis C, Chronic NCT00565539

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent disease | Prior Therapy Hepatitis C virus | peginterferon alfa-2a | peginterferon alfa-2b | Interferon-alpha | Ribavirin | Therapy naive
Item
relapsed subjects (parts 1 and 2) -- prior treatment for hcv with peg-ifn-alpha (or other ifn-alpha) and ribavirin for at least 12 weeks. naive subjects (part 3) -- no prior treatment with peg-ifn-alpha (or other ifn-alpha)
boolean
C0277556 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0391001 (UMLS CUI [3])
C0796545 (UMLS CUI [4])
C0002199 (UMLS CUI [5])
C0035525 (UMLS CUI [6])
C0919936 (UMLS CUI [7])
Hepatitis C virus RNA assay HCV genotype determination
Item
genotype 1 hcv rna greater than or equal to 100,000 iu/ml. mixed genotype hcv infection is not allowed
boolean
C1272251 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Biopsy of liver Ishak Score
Item
documented liver biopsy ≤2 years of study enrollment with ishak score ≤4
boolean
C0193388 (UMLS CUI [1,1])
C2986945 (UMLS CUI [1,2])
Absence Liver carcinoma Imaging of abdomen
Item
no evidence of hepatocellular carcinoma documented by abdominal imaging within 12 months of study entry
boolean
C0332197 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C2711454 (UMLS CUI [1,3])
Diastolic dysfunction Absent | Systolic dysfunction Absent | Echocardiogram normal | ECG normal
Item
no evidence of clinically significant diastolic or systolic dysfunction or other clinically significant abnormalities on echocardiogram or ecg
boolean
C0520863 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0749225 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0436484 (UMLS CUI [3])
C0522054 (UMLS CUI [4])
Drug abuse test Negative | Alcohol use test Negative | Exception Drug Prescriptions
Item
negative drug and alcohol tests except for physician prescribed or approved medication
boolean
C0451130 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0679532 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0033081 (UMLS CUI [3,2])
Gender Contraceptive methods Quantity | Childbearing Potential Contraceptive methods Quantity
Item
if male, or female of child-bearing potential, agrees to use 2 forms of medically accepted contraception while on study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Hypersensitivity Interferon-alpha | Hypersensitivity Ribavirin
Item
history of hypersensitivity to ifn-alpha or ribavirin
boolean
C0020517 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Substance Use Disorders
Item
active substance abuse, such as alcohol, inhaled or injection drugs within the previous 6 months
boolean
C0038586 (UMLS CUI [1])
Operative Surgical Procedures | Blood product Received
Item
undergone surgery or received blood products within 30 days prior to study enrollment
boolean
C0543467 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Cardiomyopathy | Coronary Artery Disease | Angina Pectoris | Interventional procedure Coronary Artery Disease | Angioplasty | Placement of stent | Coronary Artery Bypass Surgery | Myocardial Infarction | Tachycardia, Ventricular
Item
prior history of cardiomyopathy, coronary artery disease including angina, interventive procedure for coronary artery disease including angioplasty, stent procedure or cardiac bypass surgery, prior myocardial infarction, or ventricular tachycardia
boolean
C0878544 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C1956346 (UMLS CUI [4,2])
C0162577 (UMLS CUI [5])
C0522776 (UMLS CUI [6])
C0010055 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0042514 (UMLS CUI [9])
Hemoglobinopathy | Anemia, Hemolytic
Item
prior or current history of hemoglobinopathy or hemolytic anemia
boolean
C0019045 (UMLS CUI [1])
C0002878 (UMLS CUI [2])
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