ID

34320

Description

A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT01590641

Link

https://clinicaltrials.gov/show/NCT01590641

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT01590641

Eligibility Hepatitis B NCT01590641

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hbv infection ≥ 6 months
Description

ID.1

Data type

boolean

hbsag ≥ 250 iu/ml
Description

ID.2

Data type

boolean

hbv treatment naïve
Description

ID.3

Data type

boolean

absence of extensive bridging fibrosis (metavir 3 or greater) or cirrhosis
Description

ID.4

Data type

boolean

creatinine clearance ≥ 70 ml/min
Description

ID.5

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv), or hiv
Description

ID.6

Data type

boolean

history of gilberts disease
Description

ID.7

Data type

boolean

laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (tsh), or other evidence of hepatic decompensation
Description

ID.8

Data type

boolean

diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease(copd), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
Description

ID.9

Data type

boolean

evidence of hepatocellular carcinoma
Description

ID.10

Data type

boolean

Similar models

Eligibility Hepatitis B NCT01590641

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
chronic hbv infection ≥ 6 months
boolean
ID.2
Item
hbsag ≥ 250 iu/ml
boolean
ID.3
Item
hbv treatment naïve
boolean
ID.4
Item
absence of extensive bridging fibrosis (metavir 3 or greater) or cirrhosis
boolean
ID.5
Item
creatinine clearance ≥ 70 ml/min
boolean
Item Group
C0680251 (UMLS CUI)
ID.6
Item
co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv), or hiv
boolean
ID.7
Item
history of gilberts disease
boolean
ID.8
Item
laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (tsh), or other evidence of hepatic decompensation
boolean
ID.9
Item
diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease(copd), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
boolean
ID.10
Item
evidence of hepatocellular carcinoma
boolean

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