ID

29596

Beskrivning

Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders; ODM derived from: https://clinicaltrials.gov/show/NCT00704106

Länk

https://clinicaltrials.gov/show/NCT00704106

Nyckelord

Versioner (2)
  1. 2018-04-09 2018-04-09 -
  2. 2018-04-09 2018-04-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00704106

Engelsk

Eligibility Hepatitis B NCT00704106

1 Formulär  
Criteria
Beskrivning

Criteria

age 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
all genders and ethnicity
Beskrivning

Ethnicity All

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0444868
positive hbsag
Beskrivning

Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
hbeag positive and negative
Beskrivning

Hepatitis B e antigen positive | Hepatitis B e antigen negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
pretreatment hbv dna of 10,000 copies/ml or higher (for purposes of this study, both copies and equivalent iu measurements will be recorded and analyzed)
Beskrivning

Pretreatment Hepatitis B DNA Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3539075
UMLS CUI [1,2]
C3641250
patients who are switched to, or prescribed, entecavir after treatment with adefovir for at least 12 weeks by the providing physician.
Beskrivning

Adefovir | Change of medication | Entecavir | Entecavir prescribed

Datatyp

boolean

Alias
UMLS CUI [1]
C0050175
UMLS CUI [2]
C0580105
UMLS CUI [3]
C0971023
UMLS CUI [4,1]
C0971023
UMLS CUI [4,2]
C0278329
patients with and without prior lamivudine exposure will be enrolled but enrollment of lamivudine experienced cases will be limited to no more than 30 patients total
Beskrivning

Exposure to Lamivudine | Absence Exposure to Lamivudine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0209738
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0209738
key exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
patients who refused to consent to the study
Beskrivning

Informed Consent Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
patients younger than 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
vulnerable subjects such as pregnant women, prisoners, employees, patients with significant cognitive deficits.
Beskrivning

Vulnerable adult | Pregnant Women | Prisoners | Employee | Patients Impaired cognition

Datatyp

boolean

Alias
UMLS CUI [1]
C1562367
UMLS CUI [2]
C0033011
UMLS CUI [3]
C0033167
UMLS CUI [4]
C0599987
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C0338656
patients with prior exposure to another nucleoside for more than 2 weeks. those with prior exposure to lamivudine will be enrolled under conditions detailed above.
Beskrivning

Exposure to Nucleosides | Exception Exposure to Lamivudine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0028621
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0209738
hiv co-infection
Beskrivning

HIV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
hcv co-infection
Beskrivning

HCV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C1698259
hdv co-infection
Beskrivning

HDV Coinfection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011220
UMLS CUI [1,2]
C0275524
recipients of solid organ transplantation
Beskrivning

Solid organ transplant Recipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C1709854
patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)
Beskrivning

Steroids High dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0444956
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Similar models

Eligibility Hepatitis B NCT00704106

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Ethnicity All
Item
all genders and ethnicity
boolean
C0015031 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Hepatitis B surface antigen positive
Item
positive hbsag
boolean
C0149709 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
hbeag positive and negative
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Pretreatment Hepatitis B DNA Measurement
Item
pretreatment hbv dna of 10,000 copies/ml or higher (for purposes of this study, both copies and equivalent iu measurements will be recorded and analyzed)
boolean
C3539075 (UMLS CUI [1,1])
C3641250 (UMLS CUI [1,2])
Adefovir | Change of medication | Entecavir | Entecavir prescribed
Item
patients who are switched to, or prescribed, entecavir after treatment with adefovir for at least 12 weeks by the providing physician.
boolean
C0050175 (UMLS CUI [1])
C0580105 (UMLS CUI [2])
C0971023 (UMLS CUI [3])
C0971023 (UMLS CUI [4,1])
C0278329 (UMLS CUI [4,2])
Exposure to Lamivudine | Absence Exposure to Lamivudine
Item
patients with and without prior lamivudine exposure will be enrolled but enrollment of lamivudine experienced cases will be limited to no more than 30 patients total
boolean
C0332157 (UMLS CUI [1,1])
C0209738 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0209738 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Informed Consent Refused
Item
patients who refused to consent to the study
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Age
Item
patients younger than 18
boolean
C0001779 (UMLS CUI [1])
Vulnerable adult | Pregnant Women | Prisoners | Employee | Patients Impaired cognition
Item
vulnerable subjects such as pregnant women, prisoners, employees, patients with significant cognitive deficits.
boolean
C1562367 (UMLS CUI [1])
C0033011 (UMLS CUI [2])
C0033167 (UMLS CUI [3])
C0599987 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C0338656 (UMLS CUI [5,2])
Exposure to Nucleosides | Exception Exposure to Lamivudine
Item
patients with prior exposure to another nucleoside for more than 2 weeks. those with prior exposure to lamivudine will be enrolled under conditions detailed above.
boolean
C0332157 (UMLS CUI [1,1])
C0028621 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0209738 (UMLS CUI [2,3])
HIV coinfection
Item
hiv co-infection
boolean
C4062778 (UMLS CUI [1])
HCV coinfection
Item
hcv co-infection
boolean
C1698259 (UMLS CUI [1])
HDV Coinfection
Item
hdv co-infection
boolean
C0011220 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
Solid organ transplant Recipient
Item
recipients of solid organ transplantation
boolean
C0730400 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
Steroids High dose
Item
patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)
boolean
C0038317 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Tillbaka till toppen 

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