ID

39713

Beskrivning

Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012 AM1); ODM derived from: https://clinicaltrials.gov/show/NCT01440595

Länk

https://clinicaltrials.gov/show/NCT01440595

Nyckelord

Versioner (1)
  1. 2020-02-11 2020-02-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01440595

Engelsk

Eligibility Hepatitis C, Chronic NCT01440595

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
body weight ≥ 88 lbs and ≤ 275 lbs
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
documented chc gt2 or gt3 infection
Beskrivning

Chronic Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
no known cirrhosis
Beskrivning

Liver Cirrhosis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
Beskrivning

Agreement Contraceptive methods Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
chest x-ray within the last 6 months
Beskrivning

Chest X-ray Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0332185
eye exam within the last 6 months
Beskrivning

Eye examination Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0332185
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known to be human immunodeficiency virus (hiv) positive or co-infected with active hepatitis b virus (positive for hepatitis b surface antigen)
Beskrivning

HIV Seropositivity | HBV coinfection | Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2242656
UMLS CUI [3]
C0149709
prior approved or investigational treatment for hepatitis c
Beskrivning

Prior Therapy Hepatitis C | Investigational Therapy Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0019196
evidence of hepatocellular carcinoma
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
diabetic and/or high blood pressure with clinically significant eye exam findings
Beskrivning

Diabetic | Hypertensive disease | On examination - eye findings Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1]
C0241863
UMLS CUI [2]
C0020538
UMLS CUI [3,1]
C0437530
UMLS CUI [3,2]
C2826293
pre-existing psychiatric condition
Beskrivning

Psychiatric problem Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1306597
UMLS CUI [1,2]
C2347662
clinical diagnosis of abuse of certain substances within specified timeframes
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
known medical condition that could interfere with participation
Beskrivning

Medical condition Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
active or suspected cancer within the last 5 years
Beskrivning

Malignant Neoplasms | Malignant Neoplasm Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
Beskrivning

Pregnancy | Breast Feeding | Pregnancy Expected | Ovum Donation Expected

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
UMLS CUI [4,1]
C0242812
UMLS CUI [4,2]
C1517001
male who is planning to impregnate partner or donate sperm
Beskrivning

Gender | Reproduction Partner Planned | Sperm donation Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0035150
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0871414
UMLS CUI [3,2]
C1301732
male with a pregnant female partner
Beskrivning

Gender Partner Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
chronic hepatitis not caused by hcv
Beskrivning

Hepatitis C, Chronic | Etiology Except Hepatitis C virus

Datatyp

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
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Similar models

Eligibility Hepatitis C, Chronic NCT01440595

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight
Item
body weight ≥ 88 lbs and ≤ 275 lbs
boolean
C0005910 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
documented chc gt2 or gt3 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Liver Cirrhosis Absent
Item
no known cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Agreement Contraceptive methods Quantity
Item
agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
boolean
C0680240 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Chest X-ray Recent
Item
chest x-ray within the last 6 months
boolean
C0039985 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Eye examination Recent
Item
eye exam within the last 6 months
boolean
C0200149 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity | HBV coinfection | Hepatitis B surface antigen positive
Item
known to be human immunodeficiency virus (hiv) positive or co-infected with active hepatitis b virus (positive for hepatitis b surface antigen)
boolean
C0019699 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Prior Therapy Hepatitis C | Investigational Therapy Hepatitis C
Item
prior approved or investigational treatment for hepatitis c
boolean
C1514463 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Liver carcinoma
Item
evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Diabetic | Hypertensive disease | On examination - eye findings Clinical Significance
Item
diabetic and/or high blood pressure with clinically significant eye exam findings
boolean
C0241863 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0437530 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
Psychiatric problem Pre-existing
Item
pre-existing psychiatric condition
boolean
C1306597 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Substance Use Disorders
Item
clinical diagnosis of abuse of certain substances within specified timeframes
boolean
C0038586 (UMLS CUI [1])
Medical condition Interferes with Study Subject Participation Status
Item
known medical condition that could interfere with participation
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Malignant Neoplasms | Malignant Neoplasm Suspected
Item
active or suspected cancer within the last 5 years
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy Expected | Ovum Donation Expected
Item
female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C0242812 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Gender | Reproduction Partner Planned | Sperm donation Planned
Item
male who is planning to impregnate partner or donate sperm
boolean
C0079399 (UMLS CUI [1])
C0035150 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0871414 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Gender Partner Pregnancy
Item
male with a pregnant female partner
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Hepatitis C, Chronic | Etiology Except Hepatitis C virus
Item
chronic hepatitis not caused by hcv
boolean
C0524910 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
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