ID

39751

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01532973

Nyckelord

Versioner (1)
  1. 2020-02-16 2020-02-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 februari 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hepatitis, Viral, Human NCT01532973

Engelsk

Eligibility Hepatitis, Viral, Human NCT01532973

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Body mass index

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Hepatitis C Genotype

Datatyp

boolean

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

Exclusion Criteria

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

Coinfection Genotype

Datatyp

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
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

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

Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Neoplastic disease

Datatyp

boolean

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

Hepatitis B surface antigen positive

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

NS5A Inhibitor

Datatyp

boolean

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

Protease Inhibitors Investigational Recent

Datatyp

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
Beskrivning

Exposure to Interferon-alpha | Exposure to Ribavirin

Datatyp

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
Beskrivning

Liver disease Advanced | Decompensated liver disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C4075847
Tillbaka till toppen

Similar models

Eligibility Hepatitis, Viral, Human NCT01532973

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial