ID

14367

Beskrivning

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.; ODM derived from: https://clinicaltrials.gov/show/NCT00500539

Länk

https://clinicaltrials.gov/show/NCT00500539

Nyckelord

Versioner (1)
  1. 2016-04-12 2016-04-12 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

12 april 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00500539

Engelsk

Eligibility Asthma NCT00500539

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00500539
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 12 years old or above with moderate to severe allergic asthma
Beskrivning

age, moderate to severe allergic asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0155877
UMLS CUI [2,2]
C1299393
body weight greater than 30kg and less than 150 kg and total serum ige level greater than 30 to less than 700 iu/ml
Beskrivning

body weight, total serum IgE level

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C2229760
diagnosis of allergic asthma greater than 1 year duration, according to the american thoracic society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
Beskrivning

allergic asthma greater than 1 year duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C1960047
UMLS CUI [3]
C1960048
positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
Beskrivning

skin prick test to at least one perennial allergen

Datatyp

boolean

Alias
UMLS CUI [1]
C0430561
UMLS CUI [2,1]
C0002092
UMLS CUI [2,2]
C0330103
no clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (visit 1) and during screening period (between visit 1 and 2)
Beskrivning

asthma exacerbation

Datatyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0040223
UMLS CUI [3]
C4039704
demonstrated evidence of inadequate asthma symptom control, despite treatment with ics according to clinical features of moderate to severe persistent asthma.
Beskrivning

inadequate asthma symptom control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1274136
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C3248292
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous exposure to omalizumab
Beskrivning

previous exposure to omalizumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0966225
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332157
previous exposure to other humanized proteins or monoclonal antibodies
Beskrivning

previous exposure to other humanized proteins or monoclonal antibodies

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332157
known haha to other monoclonal antibodies
Beskrivning

known haha to other monoclonal antibodies

Datatyp

boolean

Alias
UMLS CUI [1]
C3641682
UMLS CUI [2]
C0003250
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Beskrivning

hypersensitivity to any of the study drugs or to drugs with similar chemical structures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
Beskrivning

hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0966225
active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
Beskrivning

lung disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
elevated serum ige levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin e syndrome, wiskott-aldrich syndrome or allergic bronchopulmonary aspergillosis)
Beskrivning

ige level

Datatyp

boolean

Alias
UMLS CUI [1]
C2229760
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Similar models

Eligibility Asthma NCT00500539

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00500539
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age, moderate to severe allergic asthma
Item
patients 12 years old or above with moderate to severe allergic asthma
boolean
C0001779 (UMLS CUI [1])
C0155877 (UMLS CUI [2,1])
C1299393 (UMLS CUI [2,2])
body weight, total serum IgE level
Item
body weight greater than 30kg and less than 150 kg and total serum ige level greater than 30 to less than 700 iu/ml
boolean
C0005910 (UMLS CUI [1])
C2229760 (UMLS CUI [2])
allergic asthma greater than 1 year duration
Item
diagnosis of allergic asthma greater than 1 year duration, according to the american thoracic society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
boolean
C0155877 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1960047 (UMLS CUI [2])
C1960048 (UMLS CUI [3])
skin prick test to at least one perennial allergen
Item
positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
boolean
C0430561 (UMLS CUI [1])
C0002092 (UMLS CUI [2,1])
C0330103 (UMLS CUI [2,2])
asthma exacerbation
Item
no clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (visit 1) and during screening period (between visit 1 and 2)
boolean
C0349790 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C4039704 (UMLS CUI [3])
inadequate asthma symptom control
Item
demonstrated evidence of inadequate asthma symptom control, despite treatment with ics according to clinical features of moderate to severe persistent asthma.
boolean
C1274136 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C3248292 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
previous exposure to omalizumab
Item
previous exposure to omalizumab
boolean
C0966225 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
previous exposure to other humanized proteins or monoclonal antibodies
Item
previous exposure to other humanized proteins or monoclonal antibodies
boolean
C0003250 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
known haha to other monoclonal antibodies
Item
known haha to other monoclonal antibodies
boolean
C3641682 (UMLS CUI [1])
C0003250 (UMLS CUI [2])
hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Item
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab
Item
known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
boolean
C0020517 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0966225 (UMLS CUI [1,3])
lung disease
Item
active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
boolean
C0024115 (UMLS CUI [1])
ige level
Item
elevated serum ige levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin e syndrome, wiskott-aldrich syndrome or allergic bronchopulmonary aspergillosis)
boolean
C2229760 (UMLS CUI [1])
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