ID

40904

Description

Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002); ODM derived from: https://clinicaltrials.gov/show/NCT02161510

Link

https://clinicaltrials.gov/show/NCT02161510

Keywords

Versions (1)
  1. 6/2/20 6/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02161510

English

Eligibility Hepatitis C NCT02161510

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of chronic hcv defined by positive serology for hcv or positive hcv rna for at least 6 months and detectable hcv rna in peripheral blood ≥10^5 iu/ml at screening
Description

Hepatitis C, Chronic | Serology positive Hepatitis C virus | Hepatitis C RNA positive | Hepatitis C virus RNA Detectable Peripheral blood

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0220847
UMLS CUI [3]
C0855842
UMLS CUI [4,1]
C0369335
UMLS CUI [4,2]
C3830527
UMLS CUI [4,3]
C0229664
body mass index (bmi) ≥18 to <37 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
in good health other than hcv infection with normal laboratory values
Description

Good health | Exception Hepatitis C | Laboratory Results Normal

Data type

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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
history of cancer other than adequately treated non-melanomatous skin carcinoma, malignancies which have been successfully treated ≥10 years prior with no recurrence, or cancer that is unlikely to sustain a recurrence for the duration of the trial
Description

Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Malignant Neoplasm Treated | Exception Recurrence Absent | Exception Recurrence Unlikely

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0034897
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0034897
UMLS CUI [5,3]
C0750558
history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Description

Multiple allergies | Severe allergy | Anaphylaxis Prescription Drugs | Intolerance to Prescription Drugs | Anaphylaxis Non-Prescription Drugs | Intolerance to Non-Prescription Drugs | Food anaphylaxis | Food intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0740281
UMLS CUI [2]
C2945656
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0304227
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0304227
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C0013231
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0013231
UMLS CUI [7]
C0685898
UMLS CUI [8]
C0149696
positive for hepatitis b surface antigen or human immunodeficiency virus
Description

Hepatitis B surface antigen positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0019699
had major surgery or lost 1 unit of blood within 4 weeks prior to screening
Description

Major surgery | Blood Loss Unit Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C0439148
UMLS CUI [2,3]
C1265611
qtc interval ≥470 msec (males) or ≥480 msec (females)
Description

Prolonged QTc interval | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2]
C0079399
received prior treatment with other hcv inhibitors
Description

Hepatitis C virus Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C1999216
clinical or laboratory evidence of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
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Similar models

Eligibility Hepatitis C NCT02161510

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Serology positive Hepatitis C virus | Hepatitis C RNA positive | Hepatitis C virus RNA Detectable Peripheral blood
Item
clinical diagnosis of chronic hcv defined by positive serology for hcv or positive hcv rna for at least 6 months and detectable hcv rna in peripheral blood ≥10^5 iu/ml at screening
boolean
C0524910 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0855842 (UMLS CUI [3])
C0369335 (UMLS CUI [4,1])
C3830527 (UMLS CUI [4,2])
C0229664 (UMLS CUI [4,3])
Body mass index
Item
body mass index (bmi) ≥18 to <37 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Good health | Exception Hepatitis C | Laboratory Results Normal
Item
in good health other than hcv infection with normal laboratory values
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1254595 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Endocrine System Disease Poorly controlled | Gastrointestinal Disease Poorly controlled | Cardiovascular Disease Poorly controlled | Hematological Disease Poorly controlled | Liver disease Poorly controlled | Exception Hepatitis C | Immune System Disease Poorly controlled | Kidney Disease Poorly controlled | Respiration Disorder Poorly controlled | Disorder of the genitourinary system Poorly controlled | Nervous system disorder Major Poorly controlled
Item
history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting hcv infection), immunological, renal, respiratory, genitourinary, or major neurological abnormalities 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 | Exception Skin carcinoma Treated | Exception Malignant Neoplasm Treated | Exception Recurrence Absent | Exception Recurrence Unlikely
Item
history of cancer other than adequately treated non-melanomatous skin carcinoma, malignancies which have been successfully treated ≥10 years prior with no recurrence, or cancer that is unlikely to sustain a recurrence for the duration of the trial
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0034897 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0034897 (UMLS CUI [5,2])
C0750558 (UMLS CUI [5,3])
Multiple allergies | Severe allergy | Anaphylaxis Prescription Drugs | Intolerance to Prescription Drugs | Anaphylaxis Non-Prescription Drugs | Intolerance to Non-Prescription Drugs | Food anaphylaxis | Food intolerance
Item
history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
boolean
C0740281 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
C0002792 (UMLS CUI [3,1])
C0304227 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0304227 (UMLS CUI [4,2])
C0002792 (UMLS CUI [5,1])
C0013231 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0013231 (UMLS CUI [6,2])
C0685898 (UMLS CUI [7])
C0149696 (UMLS CUI [8])
Hepatitis B surface antigen positive | HIV Seropositivity
Item
positive for hepatitis b surface antigen or human immunodeficiency virus
boolean
C0149709 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Major surgery | Blood Loss Unit Quantity
Item
had major surgery or lost 1 unit of blood within 4 weeks prior to screening
boolean
C0679637 (UMLS CUI [1])
C3163616 (UMLS CUI [2,1])
C0439148 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Prolonged QTc interval | Gender
Item
qtc interval ≥470 msec (males) or ≥480 msec (females)
boolean
C1560305 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Hepatitis C virus Inhibitor
Item
received prior treatment with other hcv inhibitors
boolean
C0220847 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
Decompensated liver disease
Item
clinical or laboratory evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
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