ID

27824

Beskrivning

CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study; ODM derived from: https://clinicaltrials.gov/show/NCT00645736

Länk

https://clinicaltrials.gov/show/NCT00645736

Nyckelord

Versioner (1)
  1. 2017-11-30 2017-11-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00645736

Engelsk

Eligibility Chronic Hepatitis B NCT00645736

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18 years and over
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
provided informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of chronic hepatitis b (hbsag documented for at least 6 months)
Beskrivning

Hepatitis B, Chronic | Hepatitis B Surface Antigens Documented

Datatyp

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C1301725
currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis b management
Beskrivning

Therapeutic procedure Against Hepadnavirus prescribed | Lamivudine | adefovir | entecavir | Tenofovir | telbivudine | Chronic Hepatitis B Management

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0019132
UMLS CUI [1,4]
C0278329
UMLS CUI [2]
C0209738
UMLS CUI [3]
C0050175
UMLS CUI [4]
C0971023
UMLS CUI [5]
C0384228
UMLS CUI [6]
C1453933
UMLS CUI [7,1]
C0524909
UMLS CUI [7,2]
C0376636
been taking current antihepadnaviral therapy for at least 6 months prior to recruitment
Beskrivning

Therapeutic procedure Against Hepadnavirus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0019132
negative tests for hiv ab, hepatitis c ab and hepatitis d ab within the previous 2 years
Beskrivning

HIV antibody negative | Hepatitis C antibody test negative | Hepatitis D antibody negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1142096
UMLS CUI [2]
C1277806
UMLS CUI [3]
C1167805
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected co-infection with hiv, hepatitis c or hepatitis d
Beskrivning

HIV coinfection | HCV coinfection | HDV Coinfection | HIV coinfection Suspected | HCV coinfection Suspected | HDV Coinfection Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
UMLS CUI [4,1]
C4062778
UMLS CUI [4,2]
C0750491
UMLS CUI [5,1]
C1698259
UMLS CUI [5,2]
C0750491
UMLS CUI [6,1]
C0011220
UMLS CUI [6,2]
C0275524
UMLS CUI [6,3]
C0750491
concomitant immunosuppression / immunomodulatory therapies
Beskrivning

Therapeutic immunosuppression | Immunomodulation

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C1963758
diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months
Beskrivning

Liver carcinoma | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0023671
current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial
Beskrivning

Study Subject Participation Status | Interventional Study | Blinded Clinical Study | Pharmaceutical Industry Clinical Study Sponsor

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3]
C2347038
UMLS CUI [4,1]
C0013185
UMLS CUI [4,2]
C2347796
current child pugh class c classification (current child pugh score > 9)
Beskrivning

Child-Pugh Clinical Classification | Child-Pugh - Total Score

Datatyp

boolean

Alias
UMLS CUI [1]
C4050412
UMLS CUI [2]
C4055253
other known or suspected cause of chronic liver disease
Beskrivning

Cause Chronic liver disease | Cause Suspected Chronic liver disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0341439
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0341439
any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.
Beskrivning

Reason Study Subject Participation Status Unfavorable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
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Similar models

Eligibility Chronic Hepatitis B NCT00645736

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18 years and over
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
provided informed consent
boolean
C0021430 (UMLS CUI [1])
Hepatitis B, Chronic | Hepatitis B Surface Antigens Documented
Item
diagnosis of chronic hepatitis b (hbsag documented for at least 6 months)
boolean
C0524909 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C1301725 (UMLS CUI [2,2])
Therapeutic procedure Against Hepadnavirus prescribed | Lamivudine | adefovir | entecavir | Tenofovir | telbivudine | Chronic Hepatitis B Management
Item
currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis b management
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0019132 (UMLS CUI [1,3])
C0278329 (UMLS CUI [1,4])
C0209738 (UMLS CUI [2])
C0050175 (UMLS CUI [3])
C0971023 (UMLS CUI [4])
C0384228 (UMLS CUI [5])
C1453933 (UMLS CUI [6])
C0524909 (UMLS CUI [7,1])
C0376636 (UMLS CUI [7,2])
Therapeutic procedure Against Hepadnavirus
Item
been taking current antihepadnaviral therapy for at least 6 months prior to recruitment
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0019132 (UMLS CUI [1,3])
HIV antibody negative | Hepatitis C antibody test negative | Hepatitis D antibody negative
Item
negative tests for hiv ab, hepatitis c ab and hepatitis d ab within the previous 2 years
boolean
C1142096 (UMLS CUI [1])
C1277806 (UMLS CUI [2])
C1167805 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
HIV coinfection | HCV coinfection | HDV Coinfection | HIV coinfection Suspected | HCV coinfection Suspected | HDV Coinfection Suspected
Item
known or suspected co-infection with hiv, hepatitis c or hepatitis d
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
C4062778 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C1698259 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0011220 (UMLS CUI [6,1])
C0275524 (UMLS CUI [6,2])
C0750491 (UMLS CUI [6,3])
Therapeutic immunosuppression | Immunomodulation
Item
concomitant immunosuppression / immunomodulatory therapies
boolean
C0021079 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
Liver carcinoma | Life Expectancy
Item
diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months
boolean
C2239176 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Study Subject Participation Status | Interventional Study | Blinded Clinical Study | Pharmaceutical Industry Clinical Study Sponsor
Item
current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C2347038 (UMLS CUI [3])
C0013185 (UMLS CUI [4,1])
C2347796 (UMLS CUI [4,2])
Child-Pugh Clinical Classification | Child-Pugh - Total Score
Item
current child pugh class c classification (current child pugh score > 9)
boolean
C4050412 (UMLS CUI [1])
C4055253 (UMLS CUI [2])
Cause Chronic liver disease | Cause Suspected Chronic liver disease
Item
other known or suspected cause of chronic liver disease
boolean
C0015127 (UMLS CUI [1,1])
C0341439 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0341439 (UMLS CUI [2,3])
Reason Study Subject Participation Status Unfavorable
Item
any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.
boolean
C0392360 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
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