ID

23791

Descrição

Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00507689

Link

https://clinicaltrials.gov/show/NCT00507689

Palavras-chave

Versões (1)
  1. 13/07/2017 13/07/2017 -
Transferido a

13 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00507689

Inglês

Eligibility Chronic Hepatitis B NCT00507689

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subjects (18-75 years of age) with either hepatitis e antigen (hbeag) positive or hbeag negative chronic hbv prior to transplant
Descrição

Adult | Age | Chronic Hepatitis B | Hepatitis B e antigen positive | Hepatitis B e Antigens Negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0392390
UMLS CUI [5,1]
C0019167
UMLS CUI [5,2]
C1513916
willing and able to provide written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
subjects with detectable antibody to hepatitis b surface antigen performed by a local laboratory result within 30 days of screening
Descrição

Antibody Hepatitis B Surface Antigen Detectable Laboratory Results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0518943
UMLS CUI [1,2]
C3830527
UMLS CUI [1,3]
C1254595
subjects must have been stable and may not have had 2 or more of the following laboratory parameters associated with decompensated liver disease: conjugated bilirubin > 1.5 x the upper limit of the normal range (uln), prothrombin time > 1.5 x uln, platelets < 60,000/mm^3, serum albumin < 3.0 g/dl
Descrição

Study Subject Stable status | Decompensated liver disease | Laboratory Parameters Quantity Absent | Bilirubin conjugated increased | Prothrombin time increased | Platelet Count measurement | Serum albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C4075847
UMLS CUI [3,1]
C0022877
UMLS CUI [3,2]
C0449381
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0332197
UMLS CUI [4]
C0855625
UMLS CUI [5]
C0151872
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0523465
must have had at least 12 weeks of center-specific prophylactic therapy including hepatitis b immunoglobulin (hbig) posttransplant
Descrição

Prophylactic treatment | Hepatitis B immune globulin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0199176
UMLS CUI [2]
C0062525
calculated creatinine clearance ≥ 40 ml/min using the cockcroft-gault equation
Descrição

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2711451
no significant evidence of ongoing deterioration of renal function
Descrição

Renal function | Deterioration Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C0868945
UMLS CUI [2,2]
C0332197
negative serum beta-human chorionic gonadotropin (for females of childbearing potential only)
Descrição

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with hbv recurrence, ie, confirmed hbv dna ≥ 400 copies/ml, following liver transplant
Descrição

Hepatitis B Recurrence | Hepatitis B DNA Measurement | Transplantation of liver Status post

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0034897
UMLS CUI [2]
C3641250
UMLS CUI [3,1]
C0023911
UMLS CUI [3,2]
C0231290
pregnant women, women who were breast feeding or who believed they may have wished to become pregnant during the course of the study
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
males and females of reproductive potential who were unwilling to use an effective method of contraception during the study and for at least 30 days from the date of last dose of study drug
Descrição

Reproductive potential Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
evidence of hepatocellular carcinoma (hcc), eg, alpha-fetoprotein > 50 ng/ml, or by any other standard of care measure or presence of multifocal hcc at the time of transplantation if transplantation was within 144 weeks of screening
Descrição

Liver carcinoma | Alpha fetoprotein measurement | Standard of Care Measures | Liver carcinoma Multifocal | Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0201539
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0079809
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0205292
UMLS CUI [5]
C0040732
prior tdf or ftc/tdf experience post-transplant or > 12 months treatment with tdf or ftc/tdf treatment pretransplant
Descrição

Tenofovir disoproxil fumarate | emtricitabine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1099776
UMLS CUI [2]
C0909839
coinfection with hepatitis c virus (by serology), hiv, or hepatitis d virus pretransplant or at screening
Descrição

HCV coinfection Serology | HIV coinfection | HDV Coinfection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C0220911
UMLS CUI [2]
C4062778
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
significant renal, cardiovascular, pulmonary, or neurological disease
Descrição

Kidney Diseases | Cardiovascular Diseases | Lung diseases | nervous system disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0027765
known hypersensitivity to the study drugs, the metabolites, or formulation excipients
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Metabolite | Hypersensitivity Pharmaceutical Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0870883
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
were likely to receive systemic drugs with nephrotoxic potential, except immunosuppressive agents (eg, cyclosporine, tacrolimus), during the course of the study
Descrição

Pharmaceutical Preparations Systemic | Effect Nephrotoxic | Immunosuppressive Agents | Cyclosporine | Tacrolimus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C1280500
UMLS CUI [2,2]
C1514118
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0085149
history of variceal bleeding or hepatic encephalopathy following orthotopic liver transplantation
Descrição

Bleeding varices | Hepatic Encephalopathy | Orthotopic liver transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0333106
UMLS CUI [2]
C0019151
UMLS CUI [3]
C0400447
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Eligibility Chronic Hepatitis B NCT00507689

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Chronic Hepatitis B | Hepatitis B e antigen positive | Hepatitis B e Antigens Negative
Item
adult subjects (18-75 years of age) with either hepatitis e antigen (hbeag) positive or hbeag negative chronic hbv prior to transplant
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0392390 (UMLS CUI [4])
C0019167 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
Informed Consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Antibody Hepatitis B Surface Antigen Detectable Laboratory Results
Item
subjects with detectable antibody to hepatitis b surface antigen performed by a local laboratory result within 30 days of screening
boolean
C0518943 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
Study Subject Stable status | Decompensated liver disease | Laboratory Parameters Quantity Absent | Bilirubin conjugated increased | Prothrombin time increased | Platelet Count measurement | Serum albumin measurement
Item
subjects must have been stable and may not have had 2 or more of the following laboratory parameters associated with decompensated liver disease: conjugated bilirubin > 1.5 x the upper limit of the normal range (uln), prothrombin time > 1.5 x uln, platelets < 60,000/mm^3, serum albumin < 3.0 g/dl
boolean
C0681850 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
C0022877 (UMLS CUI [3,1])
C0449381 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0855625 (UMLS CUI [4])
C0151872 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0523465 (UMLS CUI [7])
Prophylactic treatment | Hepatitis B immune globulin
Item
must have had at least 12 weeks of center-specific prophylactic therapy including hepatitis b immunoglobulin (hbig) posttransplant
boolean
C0199176 (UMLS CUI [1])
C0062525 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance ≥ 40 ml/min using the cockcroft-gault equation
boolean
C2711451 (UMLS CUI [1])
Renal function | Deterioration Absent
Item
no significant evidence of ongoing deterioration of renal function
boolean
C0232804 (UMLS CUI [1])
C0868945 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
negative serum beta-human chorionic gonadotropin (for females of childbearing potential only)
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis B Recurrence | Hepatitis B DNA Measurement | Transplantation of liver Status post
Item
subjects with hbv recurrence, ie, confirmed hbv dna ≥ 400 copies/ml, following liver transplant
boolean
C0019163 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
C0023911 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant women, women who were breast feeding or who believed they may have wished to become pregnant during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Reproductive potential Contraceptive methods Unwilling
Item
males and females of reproductive potential who were unwilling to use an effective method of contraception during the study and for at least 30 days from the date of last dose of study drug
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Liver carcinoma | Alpha fetoprotein measurement | Standard of Care Measures | Liver carcinoma Multifocal | Transplantation
Item
evidence of hepatocellular carcinoma (hcc), eg, alpha-fetoprotein > 50 ng/ml, or by any other standard of care measure or presence of multifocal hcc at the time of transplantation if transplantation was within 144 weeks of screening
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C2936643 (UMLS CUI [3,1])
C0079809 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0205292 (UMLS CUI [4,2])
C0040732 (UMLS CUI [5])
Tenofovir disoproxil fumarate | emtricitabine
Item
prior tdf or ftc/tdf experience post-transplant or > 12 months treatment with tdf or ftc/tdf treatment pretransplant
boolean
C1099776 (UMLS CUI [1])
C0909839 (UMLS CUI [2])
HCV coinfection Serology | HIV coinfection | HDV Coinfection
Item
coinfection with hepatitis c virus (by serology), hiv, or hepatitis d virus pretransplant or at screening
boolean
C1698259 (UMLS CUI [1,1])
C0220911 (UMLS CUI [1,2])
C4062778 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Kidney Diseases | Cardiovascular Diseases | Lung diseases | nervous system disorder
Item
significant renal, cardiovascular, pulmonary, or neurological disease
boolean
C0022658 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Metabolite | Hypersensitivity Pharmaceutical Excipient
Item
known hypersensitivity to the study drugs, the metabolites, or formulation excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0870883 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Pharmaceutical Preparations Systemic | Effect Nephrotoxic | Immunosuppressive Agents | Cyclosporine | Tacrolimus
Item
were likely to receive systemic drugs with nephrotoxic potential, except immunosuppressive agents (eg, cyclosporine, tacrolimus), during the course of the study
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1280500 (UMLS CUI [2,1])
C1514118 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0085149 (UMLS CUI [5])
Bleeding varices | Hepatic Encephalopathy | Orthotopic liver transplant
Item
history of variceal bleeding or hepatic encephalopathy following orthotopic liver transplantation
boolean
C0333106 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0400447 (UMLS CUI [3])
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