ID

27815

Descrição

Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00558493

Link

https://clinicaltrials.gov/show/NCT00558493

Palavras-chave

Versões (1)
  1. 30/11/2017 30/11/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de novembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00558493

Inglês

Eligibility Chronic Hepatitis B NCT00558493

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
hbv dna > 2,000 copies/ml at screening
Descrição

Hepatitis B DNA Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3641250
patients who have compensated liver disease (child-pugh score =<6)
Descrição

Compensated liver disease Child-Pugh - Total Score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4055253
patients without lmv resistant mutation by rfmp assay
Descrição

Absence Mutation Lamivudine Resistant | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0026882
UMLS CUI [1,3]
C0209738
UMLS CUI [1,4]
C0332325
UMLS CUI [2]
C3846158
patients who have not experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
Descrição

Viral Breakthrough Absent Measurement Quantity | Lamivudine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4053869
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0209738
patients who can submit the written consent and comply with the claims postulated of this clinical trial
Descrição

Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently receiving antiviral except lmv or corticosteroid therapy
Descrição

Antiviral Therapy | Exception Lamivudine | Exception Steroid therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0209738
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0149783
patients that previously received antiviral treatment for hepatitis b other than lamivudine in the proceeding 12 months
Descrição

Antiviral Therapy Hepatitis B | Exception Lamivudine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0209738
previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
Descrição

Interferon To be stopped | Immunomodulation To be stopped

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C1963758
UMLS CUI [2,2]
C1272691
treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
Descrição

Pharmaceutical Preparations Nephrotoxic | Pharmaceutical Preparations Hepatotoxicity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1514118
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0235378
patients who is co-infected with hcv, hdv or hiv
Descrição

HCV coinfection | HDV Coinfection | HIV coinfection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0011220
UMLS CUI [2,2]
C0275524
UMLS CUI [3]
C4062778
serious concurrent medical conditions
Descrição

Other medical condition Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
prior organ transplantation
Descrição

Organ Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029216
patient has creatinine clearance less than 60ml/min as estimated by the following formula:
Descrição

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2711451
[(140-age in years) (body weight [kg])] / [(72) (serum creatinine] [mg/dl])[note: multiply estimates by 0.85 for women]
Descrição

Estimation of creatinine clearance by Cockcroft-Gault formula | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0079399
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Similar models

Eligibility Chronic Hepatitis B NCT00558493

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B DNA Measurement
Item
hbv dna > 2,000 copies/ml at screening
boolean
C3641250 (UMLS CUI [1])
Compensated liver disease Child-Pugh - Total Score
Item
patients who have compensated liver disease (child-pugh score =<6)
boolean
C3839044 (UMLS CUI [1,1])
C4055253 (UMLS CUI [1,2])
Absence Mutation Lamivudine Resistant | Other Coding
Item
patients without lmv resistant mutation by rfmp assay
boolean
C0332197 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0209738 (UMLS CUI [1,3])
C0332325 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
Viral Breakthrough Absent Measurement Quantity | Lamivudine
Item
patients who have not experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
boolean
C4053869 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0209738 (UMLS CUI [2])
Informed Consent | Protocol Compliance
Item
patients who can submit the written consent and comply with the claims postulated of this clinical trial
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Antiviral Therapy | Exception Lamivudine | Exception Steroid therapy
Item
currently receiving antiviral except lmv or corticosteroid therapy
boolean
C0280274 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0149783 (UMLS CUI [3,2])
Antiviral Therapy Hepatitis B | Exception Lamivudine
Item
patients that previously received antiviral treatment for hepatitis b other than lamivudine in the proceeding 12 months
boolean
C0280274 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
Interferon To be stopped | Immunomodulation To be stopped
Item
previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
boolean
C3652465 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Pharmaceutical Preparations Nephrotoxic | Pharmaceutical Preparations Hepatotoxicity
Item
treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
boolean
C0013227 (UMLS CUI [1,1])
C1514118 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0235378 (UMLS CUI [2,2])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
patients who is co-infected with hcv, hdv or hiv
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Other medical condition Serious
Item
serious concurrent medical conditions
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Organ Transplantation
Item
prior organ transplantation
boolean
C0029216 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patient has creatinine clearance less than 60ml/min as estimated by the following formula:
boolean
C2711451 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Gender
Item
[(140-age in years) (body weight [kg])] / [(72) (serum creatinine] [mg/dl])[note: multiply estimates by 0.85 for women]
boolean
C2711451 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
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