ID

27816

Description

A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00605384

Link

https://clinicaltrials.gov/show/NCT00605384

Keywords

  1. 11/30/17 11/30/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 30, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis B NCT00605384

Eligibility Chronic Hepatitis B NCT00605384

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hbv infection
Description

Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524909
history of lamivudine (lvd) treatment, and lamivudine resistance (lvdr), receiving lvd at screening visit
Description

Lamivudine | Lamivudine Resistance

Data type

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2,1]
C0209738
UMLS CUI [2,2]
C1514892
compensated liver function
Description

Liver function Compensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205432
hbv dna ≥ 172,000 iu/ml
Description

Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1]
C3641250
hepatitis b e-antigen (hbeag)-positive or hbeag-negative
Description

Hepatitis B e antigen positive | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of decompensated cirrhosis
Description

Decompensated cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C1619727
coinfection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis d virus (hdv)
Description

HIV coinfection | HCV coinfection | HDV Coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
recent history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
serum alpha fetoprotein > 100 ng/ml
Description

serum alpha-fetoprotein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0546833
except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b
Description

Exception Lamivudine | Nucleoside Analogs Antiviral Agents Against Hepatitis B | Nucleotide analog Antiviral Agents Against Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0209738
UMLS CUI [2,1]
C1579410
UMLS CUI [2,2]
C0003451
UMLS CUI [2,3]
C0521124
UMLS CUI [2,4]
C0019163
UMLS CUI [3,1]
C0597107
UMLS CUI [3,2]
C0003451
UMLS CUI [3,3]
C0521124
UMLS CUI [3,4]
C0019163

Similar models

Eligibility Chronic Hepatitis B NCT00605384

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])
Lamivudine | Lamivudine Resistance
Item
history of lamivudine (lvd) treatment, and lamivudine resistance (lvdr), receiving lvd at screening visit
boolean
C0209738 (UMLS CUI [1])
C0209738 (UMLS CUI [2,1])
C1514892 (UMLS CUI [2,2])
Liver function Compensated
Item
compensated liver function
boolean
C0232741 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
Hepatitis B DNA Measurement
Item
hbv dna ≥ 172,000 iu/ml
boolean
C3641250 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
hepatitis b e-antigen (hbeag)-positive or hbeag-negative
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis
Item
evidence of decompensated cirrhosis
boolean
C1619727 (UMLS CUI [1])
HIV coinfection | HCV coinfection | HDV Coinfection
Item
coinfection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis d virus (hdv)
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Pancreatitis
Item
recent history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
serum alpha-fetoprotein measurement
Item
serum alpha fetoprotein > 100 ng/ml
boolean
C0546833 (UMLS CUI [1])
Exception Lamivudine | Nucleoside Analogs Antiviral Agents Against Hepatitis B | Nucleotide analog Antiviral Agents Against Hepatitis B
Item
except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b
boolean
C1705847 (UMLS CUI [1,1])
C0209738 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2,1])
C0003451 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0019163 (UMLS CUI [2,4])
C0597107 (UMLS CUI [3,1])
C0003451 (UMLS CUI [3,2])
C0521124 (UMLS CUI [3,3])
C0019163 (UMLS CUI [3,4])

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