ID

39682

Descrição

Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003); ODM derived from: https://clinicaltrials.gov/show/NCT02269059

Link

https://clinicaltrials.gov/show/NCT02269059

Palavras-chave

Versões (1)
  1. 10/02/2020 10/02/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de fevereiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02269059

Inglês

Eligibility Hepatitis C NCT02269059

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
is in good health except for hcv infection
Descrição

Good health | Exception Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
is male or is a female of non-childbearing potential
Descrição

Gender | Gender Childbearing Potential Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0332197
clinical diagnosis of hcv gt1 or gt3 with no evidence of mixed-gt or non-typeable infection
Descrição

Hepatitis C Genotype | Genotype Mixed Absent | Absence Hepatitis C Without Genotype

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C1148363
UMLS CUI [2,2]
C0205430
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0019196
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C1148363
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting hcv infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease
Descrição

Endocrine System Diseases Poorly controlled | Gastrointestinal Diseases Poorly controlled | Cardiovascular Diseases Poorly controlled | Hematological Disease Poorly controlled | Liver diseases Poorly controlled | Exception Hepatitis C | Immune System Diseases Poorly controlled | Kidney Diseases Poorly controlled | Respiration Disorders Poorly controlled | Disorder of the genitourinary system Poorly controlled | Nervous system disorder Major Poorly controlled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C3853134
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0019196
UMLS CUI [7,1]
C0021053
UMLS CUI [7,2]
C3853134
UMLS CUI [8,1]
C0022658
UMLS CUI [8,2]
C3853134
UMLS CUI [9,1]
C0035204
UMLS CUI [9,2]
C3853134
UMLS CUI [10,1]
C0080276
UMLS CUI [10,2]
C3853134
UMLS CUI [11,1]
C0027765
UMLS CUI [11,2]
C0205164
UMLS CUI [11,3]
C3853134
has a history of cancer
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
has a history of significant multiple and/or severe allergies
Descrição

Multiple allergies | Severe allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0740281
UMLS CUI [2]
C2945656
is positive for hepatitis b or human immunodeficiency virus
Descrição

Hepatitis B virus test positive | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2748184
UMLS CUI [2]
C0019699
has had major surgery, donated or lost 1 unit (500 ml) of blood within 4 weeks prior to screening
Descrição

Major surgery | Blood Donation Amount Recent | Blood Loss Amount Recent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C3163616
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332185
consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening
Descrição

Alcohol consumption Alcoholic Beverages U/day | Illicit medication use Regular | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0281875
UMLS CUI [2,2]
C0205272
UMLS CUI [3]
C0038586
has chronic hepatitis not caused by hcv (e.g., nonalcoholic steatohepatitis [nash])
Descrição

Hepatitis, Chronic | Etiology Except Hepatitis C virus | Nonalcoholic Steatohepatitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C3241937
has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis
Descrição

Liver disease Advanced | Decompensated liver disease | Bridging fibrosis | Fibrosis High grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C4075847
UMLS CUI [3]
C0334160
UMLS CUI [4,1]
C0016059
UMLS CUI [4,2]
C0205082
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Similar models

Eligibility Hepatitis C NCT02269059

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Good health | Exception Hepatitis C
Item
is in good health except for hcv infection
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Gender | Gender Childbearing Potential Absent
Item
is male or is a female of non-childbearing potential
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Hepatitis C Genotype | Genotype Mixed Absent | Absence Hepatitis C Without Genotype
Item
clinical diagnosis of hcv gt1 or gt3 with no evidence of mixed-gt or non-typeable infection
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1148363 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C1148363 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Endocrine System Diseases Poorly controlled | Gastrointestinal Diseases Poorly controlled | Cardiovascular Diseases Poorly controlled | Hematological Disease Poorly controlled | Liver diseases Poorly controlled | Exception Hepatitis C | Immune System Diseases Poorly controlled | Kidney Diseases Poorly controlled | Respiration Disorders Poorly controlled | Disorder of the genitourinary system Poorly controlled | Nervous system disorder Major Poorly controlled
Item
has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting hcv infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease
boolean
C0014130 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0019196 (UMLS CUI [6,2])
C0021053 (UMLS CUI [7,1])
C3853134 (UMLS CUI [7,2])
C0022658 (UMLS CUI [8,1])
C3853134 (UMLS CUI [8,2])
C0035204 (UMLS CUI [9,1])
C3853134 (UMLS CUI [9,2])
C0080276 (UMLS CUI [10,1])
C3853134 (UMLS CUI [10,2])
C0027765 (UMLS CUI [11,1])
C0205164 (UMLS CUI [11,2])
C3853134 (UMLS CUI [11,3])
Malignant Neoplasms
Item
has a history of cancer
boolean
C0006826 (UMLS CUI [1])
Multiple allergies | Severe allergy
Item
has a history of significant multiple and/or severe allergies
boolean
C0740281 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
Hepatitis B virus test positive | HIV Seropositivity
Item
is positive for hepatitis b or human immunodeficiency virus
boolean
C2748184 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Major surgery | Blood Donation Amount Recent | Blood Loss Amount Recent
Item
has had major surgery, donated or lost 1 unit (500 ml) of blood within 4 weeks prior to screening
boolean
C0679637 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C3163616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
Alcohol consumption Alcoholic Beverages U/day | Illicit medication use Regular | Substance Use Disorders
Item
consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0281875 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0038586 (UMLS CUI [3])
Hepatitis, Chronic | Etiology Except Hepatitis C virus | Nonalcoholic Steatohepatitis
Item
has chronic hepatitis not caused by hcv (e.g., nonalcoholic steatohepatitis [nash])
boolean
C0019189 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C3241937 (UMLS CUI [3])
Liver disease Advanced | Decompensated liver disease | Bridging fibrosis | Fibrosis High grade
Item
has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
C0334160 (UMLS CUI [3])
C0016059 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
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