Informatie:
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ID
39647
Beschrijving
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
Trefwoorden
Versies (1)
- 08-02-20 08-02-20 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
8 februari 2020
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01591668
Eligibility Hepatitis C NCT01591668
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT01591668
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
Pregnancy | Breast Feeding
Item
pregnant or lactating subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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])
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])
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])
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])