ID

27852

Beschrijving

Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00964665

Link

https://clinicaltrials.gov/show/NCT00964665

Trefwoorden

Versies (1)
  1. 01-12-17 01-12-17 -
Houder van rechten

See clinicaltrials.gov

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1 december 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00964665

Engels

Eligibility Chronic Hepatitis B NCT00964665

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
Beschrijving

Age | Childbearing Potential Absent | Childbearing Potential Contraceptive methods Different Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1705242
UMLS CUI [3,4]
C1265611
chronic hbv infection (serum hbsag detectable for > 6 months)
Beschrijving

Hepatitis B, Chronic | Hepatitis B Surface Antigens Detectable

Datatype

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C3830527
serum hbeag positive with hbv dna >106copies/ml (or >200,000 iu/ml)
Beschrijving

Hepatitis B e antigen positive | Hepatitis B DNA Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C3641250
serum alt must be > 2 x uln but below 10 x uln
Beschrijving

Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
steroid treatment or immunosuppression 3 months prior to entry.
Beschrijving

Steroids | Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021079
chest x-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
Beschrijving

Chest X-ray Associated with Inflammation | Lung disease | Lung Disease, Interstitial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0021368
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0206062
hb< 10g/dl or, and anc < 750/mm3 or , and platelet count < 75,000 mm3 .
Beschrijving

Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
significant chronic medical conditions other than chronic hepatitis b which in the opinion of the investigator preclude enrollment into the study.
Beschrijving

Chronic medical condition Excludes Enrollment Clinical Trial | Exception Chronic Hepatitis B

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C1516879
UMLS CUI [1,5]
C0008976
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524909
evidence of hepatic decompensation (i.e., child-pugh score of b or c).
Beschrijving

Hepatic decompensation Child-Pugh - Total Score

Datatype

boolean

Alias
UMLS CUI [1,1]
C1394798
UMLS CUI [1,2]
C4055253
seropositive for hiv, hcv, or hdv (hepatitis delta virus).
Beschrijving

HIV Seropositivity | HCV Seropositive | HDV Seropositive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0521143
history of hypothyroidism or current treatment for thyroid disease.
Beschrijving

Hypothyroidism | Therapeutic procedure Thyroid Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0020676
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0040128
patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma
Beschrijving

Malignant Neoplasm Organ Treated | Malignant Neoplasm Organ untreated | Exception Basal cell carcinoma Localized

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0332155
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C0392752
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Chronic Hepatitis B NCT00964665

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Childbearing Potential Absent | Childbearing Potential Contraceptive methods Different Quantity
Item
male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
boolean
C0001779 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Hepatitis B, Chronic | Hepatitis B Surface Antigens Detectable
Item
chronic hbv infection (serum hbsag detectable for > 6 months)
boolean
C0524909 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
Hepatitis B e antigen positive | Hepatitis B DNA Measurement
Item
serum hbeag positive with hbv dna >106copies/ml (or >200,000 iu/ml)
boolean
C0392390 (UMLS CUI [1])
C3641250 (UMLS CUI [2])
Alanine aminotransferase increased
Item
serum alt must be > 2 x uln but below 10 x uln
boolean
C0151905 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Steroids | Therapeutic immunosuppression
Item
steroid treatment or immunosuppression 3 months prior to entry.
boolean
C0038317 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
Chest X-ray Associated with Inflammation | Lung disease | Lung Disease, Interstitial
Item
chest x-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
boolean
C0039985 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0021368 (UMLS CUI [1,3])
C0024115 (UMLS CUI [2])
C0206062 (UMLS CUI [3])
Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
hb< 10g/dl or, and anc < 750/mm3 or , and platelet count < 75,000 mm3 .
boolean
C0518015 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Chronic medical condition Excludes Enrollment Clinical Trial | Exception Chronic Hepatitis B
Item
significant chronic medical conditions other than chronic hepatitis b which in the opinion of the investigator preclude enrollment into the study.
boolean
C3843040 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1516879 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C1705847 (UMLS CUI [2,1])
C0524909 (UMLS CUI [2,2])
Hepatic decompensation Child-Pugh - Total Score
Item
evidence of hepatic decompensation (i.e., child-pugh score of b or c).
boolean
C1394798 (UMLS CUI [1,1])
C4055253 (UMLS CUI [1,2])
HIV Seropositivity | HCV Seropositive | HDV Seropositive
Item
seropositive for hiv, hcv, or hdv (hepatitis delta virus).
boolean
C0019699 (UMLS CUI [1])
C0220847 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0011220 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
Hypothyroidism | Therapeutic procedure Thyroid Diseases
Item
history of hypothyroidism or current treatment for thyroid disease.
boolean
C0020676 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0040128 (UMLS CUI [2,2])
Malignant Neoplasm Organ Treated | Malignant Neoplasm Organ untreated | Exception Basal cell carcinoma Localized
Item
patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma
boolean
C0006826 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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