ID

39341

Descrição

Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT01913431

Link

https://clinicaltrials.gov/show/NCT01913431

Palavras-chave

Versões (1)
  1. 22/12/2019 22/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility HBeAg-Positive Chronic Hepatitis B NCT01913431

Inglês

Eligibility HBeAg-Positive Chronic Hepatitis B NCT01913431

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with hbeag chronic hepatitis b for at least six months starting from the screening visit
Descrição

Chronic Hepatitis B HBeAg positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0392390
subjects with hbsag-positive diagnosed at the screening visit
Descrição

HBsAg positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
subjects with hbeag-positive or hbeag-negative diagnosed at the screening visit
Descrição

HBeAg positive | HBeAg negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
for those who were diagnosed hbeag-positive, hbv dna level should be equal or more than 1x10^5 copies/ml
Descrição

HBeAg positive | Hepatitis B DNA Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C3641250
for those who were diagnosed hbeag-negative, hbv dna level should be equal or more than 1x10^5 copies/ml
Descrição

HBeAg negative | Hepatitis B DNA Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948827
UMLS CUI [2]
C3641250
subjects who were not administrated any anti-viral agents including interferon or pegylated interferon
Descrição

Antiviral Agents Absent | Interferon Absent | PEGINTERFERON Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003451
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0982327
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with hcv, hdv or hiv
Descrição

Hepatitis C | Hepatitis D Infection | HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0011226
UMLS CUI [3]
C0019693
subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
Descrição

End Stage Liver Disease | Serum total bilirubin measurement | Prothrombin time assay | Serum albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0033707
UMLS CUI [4]
C0523465
with medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
Descrição

Hemorrhage | Hepatic Encephalopathy | Liver Dysfunction Due to Ascites | Icterus | Varicosity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0019151
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0003962
UMLS CUI [4]
C0022346
UMLS CUI [5]
C0042345
less than 50ml/min of creatinine clearance diagnosed at the screening visit
Descrição

Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373595
more than 50 ng/ml of alpha-fetoprotein at the screening visit
Descrição

Alpha fetoprotein measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201539
involved in other studies
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility HBeAg-Positive Chronic Hepatitis B NCT01913431

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis B HBeAg positive
Item
subjects with hbeag chronic hepatitis b for at least six months starting from the screening visit
boolean
C0524909 (UMLS CUI [1,1])
C0392390 (UMLS CUI [1,2])
HBsAg positive
Item
subjects with hbsag-positive diagnosed at the screening visit
boolean
C0149709 (UMLS CUI [1])
HBeAg positive | HBeAg negative
Item
subjects with hbeag-positive or hbeag-negative diagnosed at the screening visit
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
HBeAg positive | Hepatitis B DNA Measurement
Item
for those who were diagnosed hbeag-positive, hbv dna level should be equal or more than 1x10^5 copies/ml
boolean
C0392390 (UMLS CUI [1])
C3641250 (UMLS CUI [2])
HBeAg negative | Hepatitis B DNA Measurement
Item
for those who were diagnosed hbeag-negative, hbv dna level should be equal or more than 1x10^5 copies/ml
boolean
C0948827 (UMLS CUI [1])
C3641250 (UMLS CUI [2])
Antiviral Agents Absent | Interferon Absent | PEGINTERFERON Absent
Item
subjects who were not administrated any anti-viral agents including interferon or pegylated interferon
boolean
C0003451 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0982327 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis C | Hepatitis D Infection | HIV Infection
Item
subjects with hcv, hdv or hiv
boolean
C0019196 (UMLS CUI [1])
C0011226 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
End Stage Liver Disease | Serum total bilirubin measurement | Prothrombin time assay | Serum albumin measurement
Item
subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
boolean
C0745744 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
C0523465 (UMLS CUI [4])
Hemorrhage | Hepatic Encephalopathy | Liver Dysfunction Due to Ascites | Icterus | Varicosity
Item
with medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
boolean
C0019080 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0003962 (UMLS CUI [3,3])
C0022346 (UMLS CUI [4])
C0042345 (UMLS CUI [5])
Creatinine clearance measurement
Item
less than 50ml/min of creatinine clearance diagnosed at the screening visit
boolean
C0373595 (UMLS CUI [1])
Alpha fetoprotein measurement
Item
more than 50 ng/ml of alpha-fetoprotein at the screening visit
boolean
C0201539 (UMLS CUI [1])
Study Subject Participation Status
Item
involved in other studies
boolean
C2348568 (UMLS CUI [1])
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