ID

27842

Descripción

Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00781105

Link

https://clinicaltrials.gov/show/NCT00781105

Palabras clave

Versiones (1)
  1. 30/11/17 30/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

30 de noviembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00781105

Inglés

Eligibility Chronic Hepatitis B NCT00781105

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female 16 to 65 year of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
documented chb defined by detectable serum hbsag and serum hbv dna level
Descripción

Hepatitis B, Chronic | Hepatitis B Surface Antigens Detectable | Hepatitis B DNA Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C3830527
UMLS CUI [3]
C3641250
willing and able to comply with the study drug regimen
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
written informed consent before any assessment
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a history of/or clinical signs/symptoms of hepatic decompensation
Descripción

Hepatic decompensation | Sign or Symptom Hepatic decompensation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C1394798
patient has a history of hcc or findings suggestive of possible hcc
Descripción

Liver carcinoma | Liver carcinoma Suggestive of

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0332299
patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
Descripción

Nucleosides Pharmaceutical Preparations | Nucleotides Pharmaceutical Preparations | Nucleosides Investigational New Drugs | Nucleotides Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0028621
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0028630
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C0028621
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C0028630
UMLS CUI [4,2]
C0013230
history of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity telbivudine | Hypersensitivity Investigational New Drugs Clinical Class Similar

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1453933
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1314971
UMLS CUI [3,4]
C2348205
patient has received ifn or other immunomodulatory treatment with 12 months before screening
Descripción

Interferons | Immunomodulation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C1963758
previous treatment history with nrtis
Descripción

Nucleoside Reverse Transcriptase Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3537103
other protocol-defined inclusion/exclusion criteria may apply.
Descripción

Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Chronic Hepatitis B NCT00781105

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female 16 to 65 year of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis B, Chronic | Hepatitis B Surface Antigens Detectable | Hepatitis B DNA Measurement
Item
documented chb defined by detectable serum hbsag and serum hbv dna level
boolean
C0524909 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C3641250 (UMLS CUI [3])
Protocol Compliance
Item
willing and able to comply with the study drug regimen
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
written informed consent before any assessment
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatic decompensation | Sign or Symptom Hepatic decompensation
Item
patient has a history of/or clinical signs/symptoms of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C1394798 (UMLS CUI [2,2])
Liver carcinoma | Liver carcinoma Suggestive of
Item
patient has a history of hcc or findings suggestive of possible hcc
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
Nucleosides Pharmaceutical Preparations | Nucleotides Pharmaceutical Preparations | Nucleosides Investigational New Drugs | Nucleotides Investigational New Drugs
Item
patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
boolean
C0028621 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0028630 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0028621 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0028630 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity telbivudine | Hypersensitivity Investigational New Drugs Clinical Class Similar
Item
history of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1453933 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1314971 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
Interferons | Immunomodulation
Item
patient has received ifn or other immunomodulatory treatment with 12 months before screening
boolean
C0021747 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
Nucleoside Reverse Transcriptase Inhibitor
Item
previous treatment history with nrtis
boolean
C3537103 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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