ID

27854

Description

Dose Escalation of Interleukin-1 (IL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B Virus (HBV) Infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01027065

Link

https://clinicaltrials.gov/show/NCT01027065

Keywords

Versions (1)
  1. 12/1/17 12/1/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT01027065

English

Eligibility Chronic Hepatitis B NCT01027065

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hbv-infected patients
Description

Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524909
hbeag-negative patients
Description

Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C0948827
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with active chronic hepatitis at the start of the antiviral treatment
Description

Hepatitis, Chronic | Antiviral Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2]
C0280274
patient with a hbv dna undetectable (<70 copies/ml) stable for at least 3 months under entecavir or tenofovir treatment.
Description

Hepatitis B virus DNA Undetectable | Entecavir Stable | Tenofovir Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0369332
UMLS CUI [1,2]
C3827727
UMLS CUI [2,1]
C0971023
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0384228
UMLS CUI [3,2]
C0205360
ongoing treatment by entecavir or tenofovir at screening note: previous treatment with pegylated ifn monotherapy, before the start of entecavir or tenofovir, is acceptable
Description

entecavir | Tenofovir | Pegylated interferon alfa Acceptable

Data type

boolean

Alias
UMLS CUI [1]
C0971023
UMLS CUI [2]
C0384228
UMLS CUI [3,1]
C0907160
UMLS CUI [3,2]
C1879533
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
infection by hcv
Description

Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019196
infection by hiv-1 and /or hiv-2
Description

HIV-1 infection | HIV-2 infection

Data type

boolean

Alias
UMLS CUI [1]
C2363741
UMLS CUI [2]
C0854094
apart from hbv infection, presence of active infection requiring a specific treatment or a hospitalization
Description

Communicable Disease Requirement Therapeutic procedure Specific | Communicable Disease Hospitalization Required | Exception Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0205369
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1708385
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019163
previous treatment by lamivudine and/or nucleosides analogues
Description

Lamivudine | Nucleoside Analogs

Data type

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C1579410
inactive carrier
Description

Carrier Without Activity

Data type

boolean

Alias
UMLS CUI [1,1]
C0560175
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0205177
cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
other liver disease (notably from alcoholic, metabolic or immunological origin)
Description

Liver disease Other | Alcoholic Liver Diseases | Liver disease Cause Metabolic | Liver disease Cause immunological

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0023896
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0311400
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0015127
UMLS CUI [4,3]
C0205470
history of clinical autoimmune disease or active auto-immune disease
Description

Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
type i diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
severe asthma, presently on chronic medications
Description

Severe asthma | Pharmaceutical Preparations chronic

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205191
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Similar models

Eligibility Chronic Hepatitis B NCT01027065

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic
Item
chronic hbv-infected patients
boolean
C0524909 (UMLS CUI [1])
Hepatitis B e antigen negative
Item
hbeag-negative patients
boolean
C0948827 (UMLS CUI [1])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis, Chronic | Antiviral Therapy
Item
patients with active chronic hepatitis at the start of the antiviral treatment
boolean
C0019189 (UMLS CUI [1])
C0280274 (UMLS CUI [2])
Hepatitis B virus DNA Undetectable | Entecavir Stable | Tenofovir Stable
Item
patient with a hbv dna undetectable (<70 copies/ml) stable for at least 3 months under entecavir or tenofovir treatment.
boolean
C0369332 (UMLS CUI [1,1])
C3827727 (UMLS CUI [1,2])
C0971023 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0384228 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
entecavir | Tenofovir | Pegylated interferon alfa Acceptable
Item
ongoing treatment by entecavir or tenofovir at screening note: previous treatment with pegylated ifn monotherapy, before the start of entecavir or tenofovir, is acceptable
boolean
C0971023 (UMLS CUI [1])
C0384228 (UMLS CUI [2])
C0907160 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis C
Item
infection by hcv
boolean
C0019196 (UMLS CUI [1])
HIV-1 infection | HIV-2 infection
Item
infection by hiv-1 and /or hiv-2
boolean
C2363741 (UMLS CUI [1])
C0854094 (UMLS CUI [2])
Communicable Disease Requirement Therapeutic procedure Specific | Communicable Disease Hospitalization Required | Exception Hepatitis B
Item
apart from hbv infection, presence of active infection requiring a specific treatment or a hospitalization
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C1708385 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
Lamivudine | Nucleoside Analogs
Item
previous treatment by lamivudine and/or nucleosides analogues
boolean
C0209738 (UMLS CUI [1])
C1579410 (UMLS CUI [2])
Carrier Without Activity
Item
inactive carrier
boolean
C0560175 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
Liver Cirrhosis
Item
cirrhosis
boolean
C0023890 (UMLS CUI [1])
Liver disease Other | Alcoholic Liver Diseases | Liver disease Cause Metabolic | Liver disease Cause immunological
Item
other liver disease (notably from alcoholic, metabolic or immunological origin)
boolean
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0023896 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0311400 (UMLS CUI [3,3])
C0023895 (UMLS CUI [4,1])
C0015127 (UMLS CUI [4,2])
C0205470 (UMLS CUI [4,3])
Autoimmune Disease
Item
history of clinical autoimmune disease or active auto-immune disease
boolean
C0004364 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Severe asthma | Pharmaceutical Preparations chronic
Item
severe asthma, presently on chronic medications
boolean
C0581126 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
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