ID

39573

Beschrijving

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

Trefwoorden

Versies (1)
  1. 30-01-20 30-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 januari 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatitis B, Chronic NCT02498275

Engels

Eligibility Hepatitis B, Chronic NCT02498275

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all population:
Beschrijving

Population All

Datatype

boolean

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

Chinese People

Datatype

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
Beschrijving

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

Datatype

boolean

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

Healthy Volunteers

Datatype

boolean

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

Disease Absent | Chronic disease Absent

Datatype

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)
Beschrijving

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

Datatype

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)
Beschrijving

Liver function | Alanine aminotransferase measurement

Datatype

boolean

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

Therapy naive | Chronic Hepatitis B

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Communicable Disease | Influenza | Gastrointestinal symptom | Illness Clinical Significance

Datatype

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
Beschrijving

Interferon therapy Chronic Hepatitis B

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0524909
Terug naar het begin van de pagina

Similar models

Eligibility Hepatitis B, Chronic NCT02498275

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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