ID

17551

Descrição

Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis; ODM derived from: https://clinicaltrials.gov/show/NCT00076336

Link

https://clinicaltrials.gov/show/NCT00076336

Palavras-chave

  1. 23/09/2016 23/09/2016 -
Transferido a

23 de setembro de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Hepatitis NCT00076336

Eligibility Hepatitis NCT00076336

  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00076336
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented decompensated chronic hepatitis b defined by all of the following: 1. clinical history compatible with decompensated chronic hepatitis b related cirrhosis;
Descrição

Hepatitis B, Chronic; Decompensated | Decompensated Chronic Hepatitis B Related Liver Cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0205434
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0205434
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0023890
2. child-turcotte-pugh score > 7 points.
Descrição

Child-Pugh-Turcotte score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3854424
evidence of hepatic cirrhosis or portal hypertension.
Descrição

Liver Cirrhosis Evidence of | Portal Hypertension Evidence of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0020541
UMLS CUI [2,2]
C0332120
other protocol-defined inclusion criteria may apply.
Descrição

Inclusion criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is pregnant or breastfeeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient is coinfected with hepatitis c virus (hcv), hepatitis d virus (hdv), or human immunodeficiency virus (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
patient previously received lamivudine, adefovir, or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog at any time
Descrição

Lamivudine | adefovir | Nucleosides Investigational Against Hepatitis B Virus | nucleotide analog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C0050175
UMLS CUI [3,1]
C0028621
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C0521124
UMLS CUI [3,4]
C0019169
UMLS CUI [4]
C0597107
patient has received interferon or other immunomodulatory treatment for hbv infection in the 12 months before screening for this study.
Descrição

interferon | Biological Response Modifier Therapy Hepatitis B

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0733470
UMLS CUI [2,1]
C0005527
UMLS CUI [2,2]
C0019163
other protocol-defined exclusion criteria may apply.
Descrição

Exclusion Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Hepatitis NCT00076336

  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00076336
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic; Decompensated | Decompensated Chronic Hepatitis B Related Liver Cirrhosis
Item
documented decompensated chronic hepatitis b defined by all of the following: 1. clinical history compatible with decompensated chronic hepatitis b related cirrhosis;
boolean
C0524909 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C0205434 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0023890 (UMLS CUI [2,4])
Child-Pugh-Turcotte score
Item
2. child-turcotte-pugh score > 7 points.
boolean
C3854424 (UMLS CUI [1])
Liver Cirrhosis Evidence of | Portal Hypertension Evidence of
Item
evidence of hepatic cirrhosis or portal hypertension.
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0020541 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Inclusion criteria Study Protocol
Item
other protocol-defined inclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
patient is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
patient is coinfected with hepatitis c virus (hcv), hepatitis d virus (hdv), or human immunodeficiency virus (hiv).
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Lamivudine | adefovir | Nucleosides Investigational Against Hepatitis B Virus | nucleotide analog
Item
patient previously received lamivudine, adefovir, or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog at any time
boolean
C0209738 (UMLS CUI [1])
C0050175 (UMLS CUI [2])
C0028621 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0521124 (UMLS CUI [3,3])
C0019169 (UMLS CUI [3,4])
C0597107 (UMLS CUI [4])
interferon | Biological Response Modifier Therapy Hepatitis B
Item
patient has received interferon or other immunomodulatory treatment for hbv infection in the 12 months before screening for this study.
boolean
C0733470 (UMLS CUI [1])
C0005527 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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