ID

39647

Description

A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01591668

Link

https://clinicaltrials.gov/show/NCT01591668

Keywords

  1. 2/8/20 2/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 8, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C NCT01591668

Eligibility Hepatitis C NCT01591668

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females 18-65 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic hcv infection for at least 6 months, treatment naive
Description

Chronic Hepatitis C Disease length | Therapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0919936
hcv viral load > 100,000 iu/ml at screening
Description

HCV viral load

Data type

boolean

Alias
UMLS CUI [1]
C1868902
monoinfection with hcv 1 genotype
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
hepatitis b surface antigen negative
Description

Hepatitis B surface antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C0919711
screening ecg without clinically significant abnormalities
Description

Electrocardiogram Abnormality Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0332197
bmi 18-33 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
creatinine clearing > 70 ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
negative pregnancy test at screening
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating subjects
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
co-infection with hepatitis b virus (hbv) or hiv
Description

HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
history of gilberts disease
Description

Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C0017551
particular abnormal laboratory parameters
Description

Laboratory test result abnormal Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0205369
diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
Description

Autoimmune Disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | Malignant Neoplasms | Hemoglobinopathy | Retinal Disease | Immunocompromised patient

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0554876
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0730607
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0019045
UMLS CUI [7]
C0035309
UMLS CUI [8]
C0085393
evidence of hepatocellular carcinoma
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
on-going alcohol abuse
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
positive uring drug screen
Description

Urine drug screen positive

Data type

boolean

Alias
UMLS CUI [1]
C0743300

Similar models

Eligibility Hepatitis C NCT01591668

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females 18-65 years old
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Disease length | Therapy naive
Item
chronic hcv infection for at least 6 months, treatment naive
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2])
HCV viral load
Item
hcv viral load > 100,000 iu/ml at screening
boolean
C1868902 (UMLS CUI [1])
Hepatitis C Genotype
Item
monoinfection with hcv 1 genotype
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis B surface antigen negative
Item
hepatitis b surface antigen negative
boolean
C0919711 (UMLS CUI [1])
Electrocardiogram Abnormality Absent
Item
screening ecg without clinically significant abnormalities
boolean
C0013798 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Body mass index
Item
bmi 18-33 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearing > 70 ml/min
boolean
C0373595 (UMLS CUI [1])
Pregnancy test negative
Item
negative pregnancy test at screening
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or hiv
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Gilbert Disease
Item
history of gilberts disease
boolean
C0017551 (UMLS CUI [1])
Laboratory test result abnormal Specific
Item
particular abnormal laboratory parameters
boolean
C0438215 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Autoimmune Disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | Malignant Neoplasms | Hemoglobinopathy | Retinal Disease | Immunocompromised patient
Item
diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
boolean
C0004364 (UMLS CUI [1])
C0554876 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0730607 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
C0035309 (UMLS CUI [7])
C0085393 (UMLS CUI [8])
Liver carcinoma
Item
evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Alcohol abuse
Item
on-going alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Urine drug screen positive
Item
positive uring drug screen
boolean
C0743300 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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