ID

36034

Beschrijving

Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002); ODM derived from: https://clinicaltrials.gov/show/NCT02392494

Link

https://clinicaltrials.gov/show/NCT02392494

Trefwoorden

Versies (1)
  1. 10-04-19 10-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02392494

Engels

Eligibility Hepatitis C NCT02392494

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female of non-child bearing potential
Beschrijving

Childbearing Potential Absent | Male infertility

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0021364
in good health other than hcv genotype (gt) 1 infection
Beschrijving

Good health | Exception Hepatitis C Genotype

Datatype

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
UMLS CUI [2,3]
C1285573
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
is mentally incapacitated or legally institutionalized
Beschrijving

Mental handicap | Institutionalized Persons

Datatype

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2]
C0376326
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 (including stroke and chronic seizures) abnormalities or diseases
Beschrijving

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 | Cerebrovascular accident Poorly controlled | Seizures chronic Poorly controlled

Datatype

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
UMLS CUI [12,1]
C0038454
UMLS CUI [12,2]
C3853134
UMLS CUI [13,1]
C0036572
UMLS CUI [13,2]
C0205191
UMLS CUI [13,3]
C3853134
has a history of cancer
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
is positive for hepatitis b surface antigen (hbsag) or human immunodeficiency virus (hiv)
Beschrijving

Hepatitis B surface antigen positive | HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0019699
has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to screening
Beschrijving

Study Subject Participation Status | Research study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
consumes >2 alcoholic beverages a day or uses illegal drugs
Beschrijving

Alcohol consumption Drinks U/day | Illicit medication use

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
UMLS CUI [2]
C0281875
has evidence or history of chronic hepatitis not caused by hcv including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, or autoimmune hepatitis
Beschrijving

Hepatitis, Chronic | Etiology Absent HCV | Viral hepatitis | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune

Datatype

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C0042721
UMLS CUI [4]
C3241937
UMLS CUI [5]
C1262760
UMLS CUI [6]
C0241910
has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy
Beschrijving

Liver disease Advanced | Decompensated liver disease | Bridging fibrosis | Fibrosis Severe Metavir score Biopsy of liver

Datatype

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
UMLS CUI [4,3]
C3888527
UMLS CUI [4,4]
C0193388
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Similar models

Eligibility Hepatitis C NCT02392494

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Absent | Male infertility
Item
male or female of non-child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021364 (UMLS CUI [2])
Good health | Exception Hepatitis C Genotype
Item
in good health other than hcv genotype (gt) 1 infection
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1285573 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Mental handicap | Institutionalized Persons
Item
is mentally incapacitated or legally institutionalized
boolean
C1306341 (UMLS CUI [1])
C0376326 (UMLS CUI [2])
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 | Cerebrovascular accident Poorly controlled | Seizures chronic 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 (including stroke and chronic seizures) abnormalities or diseases
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])
C0038454 (UMLS CUI [12,1])
C3853134 (UMLS CUI [12,2])
C0036572 (UMLS CUI [13,1])
C0205191 (UMLS CUI [13,2])
C3853134 (UMLS CUI [13,3])
Malignant Neoplasms
Item
has a history of cancer
boolean
C0006826 (UMLS CUI [1])
Hepatitis B surface antigen positive | HIV Seropositivity
Item
is positive for hepatitis b surface antigen (hbsag) or human immunodeficiency virus (hiv)
boolean
C0149709 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Study Subject Participation Status | Research study
Item
has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to screening
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2])
Alcohol consumption Drinks U/day | Illicit medication use
Item
consumes >2 alcoholic beverages a day or uses illegal drugs
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0281875 (UMLS CUI [2])
Hepatitis, Chronic | Etiology Absent HCV | Viral hepatitis | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
has evidence or history of chronic hepatitis not caused by hcv including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, or autoimmune hepatitis
boolean
C0019189 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0042721 (UMLS CUI [3])
C3241937 (UMLS CUI [4])
C1262760 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
Liver disease Advanced | Decompensated liver disease | Bridging fibrosis | Fibrosis Severe Metavir score Biopsy of liver
Item
has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy
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])
C3888527 (UMLS CUI [4,3])
C0193388 (UMLS CUI [4,4])
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