ID

39751

Description

Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002 AM1); ODM derived from: https://clinicaltrials.gov/show/NCT01532973

Link

https://clinicaltrials.gov/show/NCT01532973

Keywords

Versions (1)
  1. 2/16/20 2/16/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 16, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis, Viral, Human NCT01532973

English

Eligibility Hepatitis, Viral, Human NCT01532973

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (bmi) of 18 to ≤ 37 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
clinical diagnosis of chronic hcv infection defined by positive serology for hcv for at least 6 months and detectable hcv rna in peripheral blood ≥105 iu/ml at screening
Description

Hepatitis C, Chronic | Serology positive HCV | Hepatitis C virus RNA assay Peripheral blood

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0220847
UMLS CUI [3,1]
C1272251
UMLS CUI [3,2]
C0229664
participant must be infected with hcv gt1a, gt1b, or gt 3
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with gt1 and gt3
Description

Coinfection Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C1533728
estimated creatinine clearance of ≤70 ml/min based on the cockcroft-gault equation
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
history of stroke, chronic seizures, or major neurological disorder
Description

Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205164
history of clinically significant endocrine, gastrointestinal (excepting hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Description

Endocrine System Diseases | Gastrointestinal Diseases | Exception Hepatitis C | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system

Data type

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0017178
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019196
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0021053
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0035204
UMLS CUI [9]
C0080276
history of neoplastic disease
Description

Neoplastic disease

Data type

boolean

Alias
UMLS CUI [1]
C1882062
positive hepatitis b surface antigen at the pre-study (screening) visit
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
Description

Major surgery | Blood Donation Amount | Blood Loss Amount | Study Subject Participation Status | Research study

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C3163616
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C2348568
UMLS CUI [5]
C0681814
previous treatments (s) with nonstructural protein 5a (ns5a) inhibitors
Description

NS5A Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C3883357
<4 weeks since administration of any experimental protease inhibitor
Description

Protease Inhibitors Investigational Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0033607
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C0332185
previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of elbasvir in the study
Description

Exposure to Interferon-alpha | Exposure to Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0002199
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0035525
clinical or laboratory evidence of advanced or decompensated liver disease
Description

Liver disease Advanced | Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C4075847
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Similar models

Eligibility Hepatitis, Viral, Human NCT01532973

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
body mass index (bmi) of 18 to ≤ 37 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Hepatitis C, Chronic | Serology positive HCV | Hepatitis C virus RNA assay Peripheral blood
Item
clinical diagnosis of chronic hcv infection defined by positive serology for hcv for at least 6 months and detectable hcv rna in peripheral blood ≥105 iu/ml at screening
boolean
C0524910 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3,1])
C0229664 (UMLS CUI [3,2])
Hepatitis C Genotype
Item
participant must be infected with hcv gt1a, gt1b, or gt 3
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Coinfection Genotype
Item
co-infection with gt1 and gt3
boolean
C0275524 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
estimated creatinine clearance of ≤70 ml/min based on the cockcroft-gault equation
boolean
C2711451 (UMLS CUI [1])
Cerebrovascular accident | Seizures chronic | Nervous system disorder Major
Item
history of stroke, chronic seizures, or major neurological disorder
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Endocrine System Diseases | Gastrointestinal Diseases | Exception Hepatitis C | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system
Item
history of clinically significant endocrine, gastrointestinal (excepting hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
boolean
C0014130 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C0007222 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0021053 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0035204 (UMLS CUI [8])
C0080276 (UMLS CUI [9])
Neoplastic disease
Item
history of neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
positive hepatitis b surface antigen at the pre-study (screening) visit
boolean
C0149709 (UMLS CUI [1])
Major surgery | Blood Donation Amount | Blood Loss Amount | Study Subject Participation Status | Research study
Item
has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
boolean
C0679637 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3163616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
C0681814 (UMLS CUI [5])
NS5A Inhibitor
Item
previous treatments (s) with nonstructural protein 5a (ns5a) inhibitors
boolean
C3883357 (UMLS CUI [1])
Protease Inhibitors Investigational Recent
Item
<4 weeks since administration of any experimental protease inhibitor
boolean
C0033607 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Exposure to Interferon-alpha | Exposure to Ribavirin
Item
previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of elbasvir in the study
boolean
C0332157 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Liver disease Advanced | Decompensated liver disease
Item
clinical or laboratory evidence of advanced or decompensated liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
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