ID

39573

Description

Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02498275

Link

https://clinicaltrials.gov/show/NCT02498275

Keywords

Versions (1)
  1. 1/30/20 1/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 30, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02498275

English

Eligibility Hepatitis B, Chronic NCT02498275

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all population:
Description

Population All

Data type

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C0444868
chinese population
Description

Chinese People

Data type

boolean

Alias
UMLS CUI [1]
C0152035
adequate hematological function: platelet count greater than or equal to (>=) 100*10^9 per liter (/l), hemoglobin (hb) >= 12 grams/deciliter (g/dl) (male) or >= 11 g/dl (female), white blood cell (wbc) count >= 4*10^9/l and <= 11*10^9/l
Description

Hematologic function | Platelet Count measurement | Hemoglobin measurement | Gender | White Blood Cell Count

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0023508
healthy volunteers:
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
absence of evidence of any active or chronic disease
Description

Disease Absent | Chronic disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0332197
negative hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis b surface antigen (hbsag), hepatitis b surface antibody (hbsab), hepatitis b envelope antigen (hbeag), hepatitis b envelope antiody (hbeab) and hepatitis b core antibody (hbcab)
Description

Hepatitis B DNA Negative | Hepatitis B surface antigen negative | Hepatitis B surface antibody negative | Hepatitis B e Antigens Negative | Hepatitis Be antibody Negative | Hepatitis B core antibody (HBcAb) Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3641250
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C0919711
UMLS CUI [3]
C0744842
UMLS CUI [4,1]
C0019167
UMLS CUI [4,2]
C1513916
UMLS CUI [5,1]
C0201484
UMLS CUI [5,2]
C1513916
UMLS CUI [6,1]
C3702086
UMLS CUI [6,2]
C1513916
adequate liver function: transaminases alanine aminotransferase (alt) <= 1.0 times the upper limit of normal (uln)
Description

Liver function | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
treatment naïve chb patients:
Description

Therapy naive | Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0524909
hbsag-positive (>=250 international unit/milliliter [iu/ml]), compensated liver function, non-cirrhotic
Description

Hepatitis B surface antigen positive | Liver function Compensated | Non-cirrhotic

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205432
UMLS CUI [3]
C0439687
hbeag-positive, hbv dna >= 200,000 iu/ml or equivalent copies/ml, alt >1.5 times the uln and alt <8 times the uln
Description

Hepatitis B e antigen positive | Hepatitis B DNA Measurement | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C3641250
UMLS CUI [3]
C0151905
hbeag-negative nucleoside/nucleotide analogue-treated chb patients:
Description

Hepatitis B e Antigens Negative | Nucleoside Analogs | Nucleotide analog | Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C1579410
UMLS CUI [3]
C0597107
UMLS CUI [4]
C0524909
subjects who hbeag-seroconverted on nucleoside/nucleotide analogue therapy (treatment for 1 to 3 years prior to enrollment) with hbv dna <90 iu/ml or below a detection level acceptable by both the sponsor and investigator for at least the preceding 6 months; hbeag negative and hbeab positive
Description

Hepatitis B e Antigens Seroconversion | Nucleoside Analogs | Nucleotide analog | Hepatitis B DNA Measurement | Hepatitis B DNA Undetectable | Hepatitis B e Antigens Negative | Hepatitis B e antibody positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C4042908
UMLS CUI [2]
C1579410
UMLS CUI [3]
C0597107
UMLS CUI [4]
C3641250
UMLS CUI [5,1]
C3641250
UMLS CUI [5,2]
C3827727
UMLS CUI [6,1]
C0019167
UMLS CUI [6,2]
C1513916
UMLS CUI [7]
C3203521
hbsag-positive (>=250 iu/ml), compensated liver function, non-cirrhotic -alt <= 1*uln
Description

Hepatitis B surface antigen positive | Liver function Compensated | Non-cirrhotic | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205432
UMLS CUI [3]
C0439687
UMLS CUI [4]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of steroids or other immune suppressive agents within the last 4 weeks that would impact the number/functions of white blood cells (wbc)
Description

Steroid use Impact White blood cell number | Immunosuppressive Agents Impact White blood cell number | Steroid use Impact Leukocyte function | Immunosuppressive Agents Impact Leukocyte function

Data type

boolean

Alias
UMLS CUI [1,1]
C0281991
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0427512
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0427512
UMLS CUI [3,1]
C0281991
UMLS CUI [3,2]
C4049986
UMLS CUI [3,3]
C0023516
UMLS CUI [3,4]
C0031843
UMLS CUI [4,1]
C0021081
UMLS CUI [4,2]
C4049986
UMLS CUI [4,3]
C0023516
UMLS CUI [4,4]
C0031843
any other diseases or clinical laboratory finding giving reasonable suspicion of a disease or condition (including, but not limited to, cancer, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease) that could confound the result of the study
Description

Comorbidity | Laboratory test finding | Disease Interferes with Research results | Condition Interferes with Research results | Malignant Neoplasms | Lupus Erythematosus | Rheumatoid Arthritis | Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0587081
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0409974
UMLS CUI [7]
C0003873
UMLS CUI [8]
C0004364
positive hepatitis a immunoglobulin m (igm) antibody, hepatitis c antibody (hcv ab) or human immunodeficiency virus (hiv) at screening
Description

Hepatitis A virus IgM antibody positive | Hepatitis C antibody positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C1096503
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
significant acute infection, example; influenza, acute gastrointestinal symptoms or any other clinically significant illness within 2 weeks
Description

Communicable Disease | Influenza | Gastrointestinal symptom | Illness Clinical Significance

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0021400
UMLS CUI [3]
C0426576
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C2826293
previous/concurrent treatment with interferon-based therapy for chb
Description

Interferon therapy Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0524909
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Similar models

Eligibility Hepatitis B, Chronic NCT02498275

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Population All
Item
all population:
boolean
C1257890 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Chinese People
Item
chinese population
boolean
C0152035 (UMLS CUI [1])
Hematologic function | Platelet Count measurement | Hemoglobin measurement | Gender | White Blood Cell Count
Item
adequate hematological function: platelet count greater than or equal to (>=) 100*10^9 per liter (/l), hemoglobin (hb) >= 12 grams/deciliter (g/dl) (male) or >= 11 g/dl (female), white blood cell (wbc) count >= 4*10^9/l and <= 11*10^9/l
boolean
C0221130 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
Healthy Volunteers
Item
healthy volunteers:
boolean
C1708335 (UMLS CUI [1])
Disease Absent | Chronic disease Absent
Item
absence of evidence of any active or chronic disease
boolean
C0012634 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hepatitis B DNA Negative | Hepatitis B surface antigen negative | Hepatitis B surface antibody negative | Hepatitis B e Antigens Negative | Hepatitis Be antibody Negative | Hepatitis B core antibody (HBcAb) Negative
Item
negative hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis b surface antigen (hbsag), hepatitis b surface antibody (hbsab), hepatitis b envelope antigen (hbeag), hepatitis b envelope antiody (hbeab) and hepatitis b core antibody (hbcab)
boolean
C3641250 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0919711 (UMLS CUI [2])
C0744842 (UMLS CUI [3])
C0019167 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0201484 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C3702086 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
Liver function | Alanine aminotransferase measurement
Item
adequate liver function: transaminases alanine aminotransferase (alt) <= 1.0 times the upper limit of normal (uln)
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Therapy naive | Chronic Hepatitis B
Item
treatment naïve chb patients:
boolean
C0919936 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
Hepatitis B surface antigen positive | Liver function Compensated | Non-cirrhotic
Item
hbsag-positive (>=250 international unit/milliliter [iu/ml]), compensated liver function, non-cirrhotic
boolean
C0149709 (UMLS CUI [1])
C0232741 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
C0439687 (UMLS CUI [3])
Hepatitis B e antigen positive | Hepatitis B DNA Measurement | Alanine aminotransferase increased
Item
hbeag-positive, hbv dna >= 200,000 iu/ml or equivalent copies/ml, alt >1.5 times the uln and alt <8 times the uln
boolean
C0392390 (UMLS CUI [1])
C3641250 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Hepatitis B e Antigens Negative | Nucleoside Analogs | Nucleotide analog | Chronic Hepatitis B
Item
hbeag-negative nucleoside/nucleotide analogue-treated chb patients:
boolean
C0019167 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2])
C0597107 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
Hepatitis B e Antigens Seroconversion | Nucleoside Analogs | Nucleotide analog | Hepatitis B DNA Measurement | Hepatitis B DNA Undetectable | Hepatitis B e Antigens Negative | Hepatitis B e antibody positive
Item
subjects who hbeag-seroconverted on nucleoside/nucleotide analogue therapy (treatment for 1 to 3 years prior to enrollment) with hbv dna <90 iu/ml or below a detection level acceptable by both the sponsor and investigator for at least the preceding 6 months; hbeag negative and hbeab positive
boolean
C0019167 (UMLS CUI [1,1])
C4042908 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2])
C0597107 (UMLS CUI [3])
C3641250 (UMLS CUI [4])
C3641250 (UMLS CUI [5,1])
C3827727 (UMLS CUI [5,2])
C0019167 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
C3203521 (UMLS CUI [7])
Hepatitis B surface antigen positive | Liver function Compensated | Non-cirrhotic | Alanine aminotransferase measurement
Item
hbsag-positive (>=250 iu/ml), compensated liver function, non-cirrhotic -alt <= 1*uln
boolean
C0149709 (UMLS CUI [1])
C0232741 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
C0439687 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Steroid use Impact White blood cell number | Immunosuppressive Agents Impact White blood cell number | Steroid use Impact Leukocyte function | Immunosuppressive Agents Impact Leukocyte function
Item
use of steroids or other immune suppressive agents within the last 4 weeks that would impact the number/functions of white blood cells (wbc)
boolean
C0281991 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0427512 (UMLS CUI [1,3])
C0021081 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0427512 (UMLS CUI [2,3])
C0281991 (UMLS CUI [3,1])
C4049986 (UMLS CUI [3,2])
C0023516 (UMLS CUI [3,3])
C0031843 (UMLS CUI [3,4])
C0021081 (UMLS CUI [4,1])
C4049986 (UMLS CUI [4,2])
C0023516 (UMLS CUI [4,3])
C0031843 (UMLS CUI [4,4])
Comorbidity | Laboratory test finding | Disease Interferes with Research results | Condition Interferes with Research results | Malignant Neoplasms | Lupus Erythematosus | Rheumatoid Arthritis | Autoimmune Disease
Item
any other diseases or clinical laboratory finding giving reasonable suspicion of a disease or condition (including, but not limited to, cancer, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease) that could confound the result of the study
boolean
C0009488 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0006826 (UMLS CUI [5])
C0409974 (UMLS CUI [6])
C0003873 (UMLS CUI [7])
C0004364 (UMLS CUI [8])
Hepatitis A virus IgM antibody positive | Hepatitis C antibody positive | HIV Seropositivity
Item
positive hepatitis a immunoglobulin m (igm) antibody, hepatitis c antibody (hcv ab) or human immunodeficiency virus (hiv) at screening
boolean
C1096503 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Communicable Disease | Influenza | Gastrointestinal symptom | Illness Clinical Significance
Item
significant acute infection, example; influenza, acute gastrointestinal symptoms or any other clinically significant illness within 2 weeks
boolean
C0009450 (UMLS CUI [1])
C0021400 (UMLS CUI [2])
C0426576 (UMLS CUI [3])
C0221423 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
Interferon therapy Chronic Hepatitis B
Item
previous/concurrent treatment with interferon-based therapy for chb
boolean
C0279030 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
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