ID

44537

Description

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002); ODM derived from: https://clinicaltrials.gov/show/NCT01554189

Link

https://clinicaltrials.gov/show/NCT01554189

Keywords

Versions (2)
  1. 5/21/20 5/21/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01554189

English

Eligibility Hepatitis C, Chronic NCT01554189

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
diagnosis of chronic hcv infection
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
must be infected with hcv gt1a, gt1b, or gt3
Description

Patient Infected Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439663
UMLS CUI [1,3]
C1533728
Exclusion Criteria
Description

Exclusion Criteria

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

HCV coinfection Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C1533728
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
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
history of human immunodeficiency virus (hiv) infection or positive hiv serology
Description

HIV Infection | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019699
major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior
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
history of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0740281
UMLS CUI [2]
C2945656
UMLS CUI [3]
C0577628
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0304227
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C0013231
UMLS CUI [6,1]
C0002792
UMLS CUI [6,2]
C0016452
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0304227
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0013231
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C0016452
current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
Description

Illicit medication use | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2]
C0038586
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, autoimmune hepatitis
Description

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

Data type

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]
C4721555
previous treatments(s) with nonstructural 5a (ns5a) protein inhibitors
Description

Hepatitis C virus NS5A inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C4041197
treatment with protease inhibitor(s) <30 days prior to study enrollment
Description

Protease Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0033607
previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of mk-8325 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; evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy
Description

Liver disease Advanced | Decompensated Liver Disease | Bridging fibrosis | Fibrosis METAVIR Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0745744
UMLS CUI [3]
C0334160
UMLS CUI [4,1]
C0016059
UMLS CUI [4,2]
C3897040
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Similar models

Eligibility Hepatitis C, Chronic NCT01554189

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
Item
diagnosis of chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
Patient Infected Hepatitis C virus genotype
Item
must be infected with hcv gt1a, gt1b, or gt3
boolean
C0030705 (UMLS CUI [1,1])
C0439663 (UMLS CUI [1,2])
C1533728 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
HCV coinfection Genotype
Item
co-infection with gt1 and gt3 hcv
boolean
C1698259 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
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
boolean
C0149709 (UMLS CUI [1])
HIV Infection | HIV Seropositivity
Item
history of human immunodeficiency virus (hiv) infection or positive hiv serology
boolean
C0019693 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Major surgery | Blood Donation Amount | Blood Loss Amount | Study Subject Participation Status | Research study
Item
major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior
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])
Multiple allergies | Severe allergy | Latex allergy | Anaphylaxis Prescription Drugs | Anaphylaxis Non-Prescription Drugs | Anaphylaxis Food | Intolerance to Prescription Drugs | Intolerance to Non-Prescription Drugs | Intolerance to Food
Item
history of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
boolean
C0740281 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
C0577628 (UMLS CUI [3])
C0002792 (UMLS CUI [4,1])
C0304227 (UMLS CUI [4,2])
C0002792 (UMLS CUI [5,1])
C0013231 (UMLS CUI [5,2])
C0002792 (UMLS CUI [6,1])
C0016452 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0304227 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0013231 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0016452 (UMLS CUI [9,2])
Illicit medication use | Substance Use Disorders
Item
current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
boolean
C0281875 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Hepatitis, Chronic | Etiology Absent Hepatitis C virus | Viral hepatitis | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Autoimmune hepatitis
Item
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, 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])
C4721555 (UMLS CUI [6])
Hepatitis C virus NS5A inhibitor
Item
previous treatments(s) with nonstructural 5a (ns5a) protein inhibitors
boolean
C4041197 (UMLS CUI [1])
Protease Inhibitors
Item
treatment with protease inhibitor(s) <30 days prior to study enrollment
boolean
C0033607 (UMLS CUI [1])
Exposure to Interferon-alpha | Exposure to Ribavirin
Item
previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of mk-8325 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 | Bridging fibrosis | Fibrosis METAVIR Score
Item
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])
C0745744 (UMLS CUI [2])
C0334160 (UMLS CUI [3])
C0016059 (UMLS CUI [4,1])
C3897040 (UMLS CUI [4,2])
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