ID

30558

Descripción

Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT01026610

Link

https://clinicaltrials.gov/show/NCT01026610

Palabras clave

Versiones (2)
  1. 14/6/18 14/6/18 -
  2. 27/9/21 27/9/21 -
Titular de derechos de autor

see clinical trials.gov

Subido en

14 de junio de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Chronic Hepatitis B NCT01026610

Inglés

Eligibility Chronic Hepatitis B NCT01026610

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
female or male, 18 to 65 years of age, inclusive
Descripción

Gender; Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
chronic hepatitis b
Descripción

Hepatitis B, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524909
not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before screening
Descripción

Therapeutic procedure, Virus Diseases Before Screening procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0042769
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0220908
not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within screening
Descripción

Therapeutic procedure, Virus Diseases Before Screening procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0042769
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0220908
compensated chronic hepatitis b
Descripción

Hepatitis B, Chronic, Compensated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0205432
hbeag positive or hbeag negative
Descripción

Hepatitis B e antigen positive; Hepatitis B e antigen negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
elevated serum alt level (1.2-10 x uln, inclusive)
Descripción

ALT (SGPT) level raised

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1443982
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis c or d virus (hcv or hdv) or hiv
Descripción

HCV coinfection; HDV confection; HIV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0011220
UMLS CUI [2,2]
C0275524
UMLS CUI [3]
C4062778
decompensated liver disease
Descripción

Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4075847
creatinine clearance (calculated by cockroft-gault formula) less than 50 ml/min
Descripción

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2711451
screening alpha-fetoprotein (afp) value greater than or equal to 50 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc
Descripción

serum alpha-fetoprotein (AFP) measurement; Liver carcinoma, Ultrasonography

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0546833
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0041618
treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
Descripción

Immunomodulation, Previous; Adrenal Cortex Hormones, Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205156
pregnancy or breast-feeding
Descripción

Pregnancy; Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient is currently abusing alcohol or illicit drugs
Descripción

Alcohol abuse; Illicit Drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0086190
UMLS CUI [2,2]
C0013146
significant systemic illnesses other than liver diseases
Descripción

Systemic disease, Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C2826293
presence of other causes of liver disease
Descripción

Liver diseases, Etiology aspects

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
a history of organ transplantation
Descripción

Organ Transplantation, Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205156
presence of anti-hbs at screening
Descripción

Anti-HBs antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948254
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Similar models

Eligibility Chronic Hepatitis B NCT01026610

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender; Age
Item
female or male, 18 to 65 years of age, inclusive
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis B, Chronic
Item
chronic hepatitis b
boolean
C0524909 (UMLS CUI [1])
Therapeutic procedure, Virus Diseases Before Screening procedure
Item
not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before screening
boolean
C0087111 (UMLS CUI [1,1])
C0042769 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Therapeutic procedure, Virus Diseases Before Screening procedure
Item
not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within screening
boolean
C0087111 (UMLS CUI [1,1])
C0042769 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Hepatitis B, Chronic, Compensated
Item
compensated chronic hepatitis b
boolean
C0524909 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
Hepatitis B e antigen positive; Hepatitis B e antigen negative
Item
hbeag positive or hbeag negative
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
ALT (SGPT) level raised
Item
elevated serum alt level (1.2-10 x uln, inclusive)
boolean
C1443982 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HCV coinfection; HDV confection; HIV coinfection
Item
co-infection with hepatitis c or d virus (hcv or hdv) or hiv
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Decompensated liver disease
Item
decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance (calculated by cockroft-gault formula) less than 50 ml/min
boolean
C2711451 (UMLS CUI [1])
serum alpha-fetoprotein (AFP) measurement; Liver carcinoma, Ultrasonography
Item
screening alpha-fetoprotein (afp) value greater than or equal to 50 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc
boolean
C0546833 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
Immunomodulation, Previous; Adrenal Cortex Hormones, Previous
Item
treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
boolean
C1963758 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Pregnancy; Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcohol abuse; Illicit Drug abuse
Item
patient is currently abusing alcohol or illicit drugs
boolean
C0085762 (UMLS CUI [1])
C0086190 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
Systemic disease, Clinical Significance
Item
significant systemic illnesses other than liver diseases
boolean
C0442893 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Liver diseases, Etiology aspects
Item
presence of other causes of liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Organ Transplantation, Previous
Item
a history of organ transplantation
boolean
C0029216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Anti-HBs antibody
Item
presence of anti-hbs at screening
boolean
C0948254 (UMLS CUI [1])
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