ID

19978

Description

Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00388674

Link

https://clinicaltrials.gov/show/NCT00388674

Keywords

Versions (1)
  1. 2/1/17 2/1/17 -
Uploaded on

February 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00388674

English

Eligibility Chronic Hepatitis B NCT00388674

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hbv infection
Description

Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524909
hbv nucleoside/tide-naive or -experienced
Description

Hepatitis B Virus Nucleosides Therapy naive | Hepatitis B Virus Nucleotides Therapy naive | Hepatitis B Virus Nucleosides Therapeutic procedure | Hepatitis B Virus Nucleotides Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0019169
UMLS CUI [1,2]
C0028621
UMLS CUI [1,3]
C0919936
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C0028630
UMLS CUI [2,3]
C0919936
UMLS CUI [3,1]
C0019169
UMLS CUI [3,2]
C0028621
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0019169
UMLS CUI [4,2]
C0028630
UMLS CUI [4,3]
C0087111
patients who, in opinion of investigator, are appropriate for initiating or modifying their hbv therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either etv or another standard of care hbv nucleoside/tide analogue
Description

Patients Appropriate Hepatitis B Virus Therapeutic procedure | Nucleosides Therapeutic procedure entecavir | Nucleotides Therapeutic procedure entecavir | Nucleoside Analogs Hepatitis B Virus Standard of Care | Nucleotide analog Hepatitis B Virus Standard of Care

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0019169
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0028621
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0971023
UMLS CUI [3,1]
C0028630
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0971023
UMLS CUI [4,1]
C1579410
UMLS CUI [4,2]
C0019169
UMLS CUI [4,3]
C2936643
UMLS CUI [5,1]
C0597107
UMLS CUI [5,2]
C0019169
UMLS CUI [5,3]
C2936643
age 16 and older or minimum age required in a given country
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year
Description

Life Expectancy Liver Transplant Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0023911
UMLS CUI [1,3]
C0332296
patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance
Description

Therapeutic procedure Controlled virological | Clinical Response | Therapy change Due to Medication intolerance

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2587213
UMLS CUI [1,3]
C0205466
UMLS CUI [2]
C4055223
UMLS CUI [3,1]
C3665894
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C2321306
coinfection with hiv
Description

Human immunodeficiency virus (HIV) coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
history of malignant neoplasm(s), including hepatocellular carcinoma (hcc) and carcinoma in situ (cis), but excluding non-melanoma skin cancers
Description

Malignant Neoplasms | Liver carcinoma | Carcinoma in Situ | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C2239176
UMLS CUI [3]
C0007099
UMLS CUI [4]
C0699893
patients with chronic renal insufficiency, defined as a creatinine clearance < 50 ml/min who do not have either of the following means of dose reducing etv:
Description

Chronic Kidney Insufficiency | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0403447
UMLS CUI [2]
C0373595
i. an approved country-specific etv label which includes the extended interval etv dose modification method and/or ii. an approved country specific label for the etv oral solution and access to the oral solution
Description

entecavir Extended interval dosing | entecavir Oral Solution

Data type

boolean

Alias
UMLS CUI [1,1]
C0971023
UMLS CUI [1,2]
C1979887
UMLS CUI [2]
C1577207
history of dysplastic liver nodules
Description

Liver Dysplastic Nodule

Data type

boolean

Alias
UMLS CUI [1]
C1333964
known history of allergy to nucleoside/tide analogues
Description

Hypersensitivity Nucleoside Analogs | Hypersensitivity Nucleotide analog

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1579410
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0597107
prior or current treatment with entecavir
Description

entecavir

Data type

boolean

Alias
UMLS CUI [1]
C0971023
an investigator proposed study regimen which will include only interferon-alfa
Description

Study Protocol Interferon-alpha only

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0002199
UMLS CUI [1,3]
C0205171
an investigator proposed study regimen of combination (two or more) hbv nucleoside/tide analogues
Description

Combination Quantity | Hepatitis B Virus Nucleoside Analogs | Hepatitis B Virus Nucleotide analog

Data type

boolean

Alias
UMLS CUI [1,1]
C0205195
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C1579410
UMLS CUI [3,1]
C0019169
UMLS CUI [3,2]
C0597107
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Similar models

Eligibility Chronic Hepatitis B NCT00388674

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic
Item
chronic hbv infection
boolean
C0524909 (UMLS CUI [1])
Hepatitis B Virus Nucleosides Therapy naive | Hepatitis B Virus Nucleotides Therapy naive | Hepatitis B Virus Nucleosides Therapeutic procedure | Hepatitis B Virus Nucleotides Therapeutic procedure
Item
hbv nucleoside/tide-naive or -experienced
boolean
C0019169 (UMLS CUI [1,1])
C0028621 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C0019169 (UMLS CUI [2,1])
C0028630 (UMLS CUI [2,2])
C0919936 (UMLS CUI [2,3])
C0019169 (UMLS CUI [3,1])
C0028621 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0019169 (UMLS CUI [4,1])
C0028630 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
Patients Appropriate Hepatitis B Virus Therapeutic procedure | Nucleosides Therapeutic procedure entecavir | Nucleotides Therapeutic procedure entecavir | Nucleoside Analogs Hepatitis B Virus Standard of Care | Nucleotide analog Hepatitis B Virus Standard of Care
Item
patients who, in opinion of investigator, are appropriate for initiating or modifying their hbv therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either etv or another standard of care hbv nucleoside/tide analogue
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0019169 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0028621 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0971023 (UMLS CUI [2,3])
C0028630 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0971023 (UMLS CUI [3,3])
C1579410 (UMLS CUI [4,1])
C0019169 (UMLS CUI [4,2])
C2936643 (UMLS CUI [4,3])
C0597107 (UMLS CUI [5,1])
C0019169 (UMLS CUI [5,2])
C2936643 (UMLS CUI [5,3])
Age
Item
age 16 and older or minimum age required in a given country
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy Liver Transplant Free of
Item
patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year
boolean
C0023671 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
Therapeutic procedure Controlled virological | Clinical Response | Therapy change Due to Medication intolerance
Item
patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance
boolean
C0087111 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C0205466 (UMLS CUI [1,3])
C4055223 (UMLS CUI [2])
C3665894 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C2321306 (UMLS CUI [3,3])
Human immunodeficiency virus (HIV) coinfection
Item
coinfection with hiv
boolean
C4062778 (UMLS CUI [1])
Malignant Neoplasms | Liver carcinoma | Carcinoma in Situ | Skin carcinoma
Item
history of malignant neoplasm(s), including hepatocellular carcinoma (hcc) and carcinoma in situ (cis), but excluding non-melanoma skin cancers
boolean
C0006826 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
C0007099 (UMLS CUI [3])
C0699893 (UMLS CUI [4])
Chronic Kidney Insufficiency | Creatinine clearance measurement
Item
patients with chronic renal insufficiency, defined as a creatinine clearance < 50 ml/min who do not have either of the following means of dose reducing etv:
boolean
C0403447 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
entecavir Extended interval dosing | entecavir Oral Solution
Item
i. an approved country-specific etv label which includes the extended interval etv dose modification method and/or ii. an approved country specific label for the etv oral solution and access to the oral solution
boolean
C0971023 (UMLS CUI [1,1])
C1979887 (UMLS CUI [1,2])
C1577207 (UMLS CUI [2])
Liver Dysplastic Nodule
Item
history of dysplastic liver nodules
boolean
C1333964 (UMLS CUI [1])
Hypersensitivity Nucleoside Analogs | Hypersensitivity Nucleotide analog
Item
known history of allergy to nucleoside/tide analogues
boolean
C0020517 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0597107 (UMLS CUI [2,2])
entecavir
Item
prior or current treatment with entecavir
boolean
C0971023 (UMLS CUI [1])
Study Protocol Interferon-alpha only
Item
an investigator proposed study regimen which will include only interferon-alfa
boolean
C2348563 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
Combination Quantity | Hepatitis B Virus Nucleoside Analogs | Hepatitis B Virus Nucleotide analog
Item
an investigator proposed study regimen of combination (two or more) hbv nucleoside/tide analogues
boolean
C0205195 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0019169 (UMLS CUI [2,1])
C1579410 (UMLS CUI [2,2])
C0019169 (UMLS CUI [3,1])
C0597107 (UMLS CUI [3,2])
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