ID

29597

Description

Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00722332

Link

https://clinicaltrials.gov/show/NCT00722332

Keywords

Versions (1)
  1. 4/10/18 4/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00722332

English

Eligibility Hepatitis B NCT00722332

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
hbsag-positive candidates for hbv-related liver transplant
Description

Hepatitis B surface antigen positive | Transplantation of liver Relationship Hepatitis B Virus Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0023911
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0019169
UMLS CUI [2,4]
C3840775
treatment with antiviral therapy before transplantation as per treating physician's recommendation. (note: it is expected that most patients will receive lamivudine or adefovir dipivoxil pre-transplant. in the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)
Description

Antiviral Therapy Before Transplantation | Lamivudine | adefovir dipivoxil

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0040732
UMLS CUI [2]
C0209738
UMLS CUI [3]
C0540694
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
multi-organ transplantation recipients
Description

Recipient Organ Transplantation multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0029216
UMLS CUI [1,3]
C0439064
liver re-transplantation except for primary non-function
Description

Liver retransplantation | Exception primary failure of transplanted liver

Data type

boolean

Alias
UMLS CUI [1]
C4087552
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2728977
presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (milan criteria) based on information available at baseline visit (ct scan, mri).
Description

Hepatoma | Size Node Solitary | Size Nodes Multifocal | CT scan | MRI

Data type

boolean

Alias
UMLS CUI [1]
C0023903
UMLS CUI [2,1]
C0456389
UMLS CUI [2,2]
C0024204
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0456389
UMLS CUI [3,2]
C0024204
UMLS CUI [3,3]
C0205292
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
patients requiring an olt (orthotopic liver transplant)due to fulminant hepatitis b
Description

Orthotopic liver transplant Due to Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0400447
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019163
olt patients receiving a liver graft from a donor that is positive for hbsag
Description

Orthotopic liver transplant | Liver graft Donor Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0400447
UMLS CUI [2,1]
C1720613
UMLS CUI [2,2]
C0013018
UMLS CUI [2,3]
C0149709
patients using interferon pre-transplant (as interferon cannot be used post-transplant)
Description

Interferon prior to Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0040732
history of iga (immunoglobulin a) deficiency
Description

Immunoglobulin A deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0162538
history of hypersensitivity to blood products.
Description

Hypersensitivity Blood product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0456388
hiv or hcv positive
Description

HIV Seropositivity | Hepatitis C virus Positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C1514241
use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)
Description

Investigational New Drugs | Study Subject Participation Status | Exception Quality of life Clinical Trials | Exception Repository Clinical Trials

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0034380
UMLS CUI [3,3]
C0008976
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3847505
UMLS CUI [4,3]
C0008976
pregnancy or planned pregnancy during the course of the study
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Hepatitis B NCT00722332

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Hepatitis B surface antigen positive | Transplantation of liver Relationship Hepatitis B Virus Anticipated
Item
hbsag-positive candidates for hbv-related liver transplant
boolean
C0149709 (UMLS CUI [1])
C0023911 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0019169 (UMLS CUI [2,3])
C3840775 (UMLS CUI [2,4])
Antiviral Therapy Before Transplantation | Lamivudine | adefovir dipivoxil
Item
treatment with antiviral therapy before transplantation as per treating physician's recommendation. (note: it is expected that most patients will receive lamivudine or adefovir dipivoxil pre-transplant. in the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)
boolean
C0280274 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
C0209738 (UMLS CUI [2])
C0540694 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Recipient Organ Transplantation multiple
Item
multi-organ transplantation recipients
boolean
C1709854 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
Liver retransplantation | Exception primary failure of transplanted liver
Item
liver re-transplantation except for primary non-function
boolean
C4087552 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2728977 (UMLS CUI [2,2])
Hepatoma | Size Node Solitary | Size Nodes Multifocal | CT scan | MRI
Item
presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (milan criteria) based on information available at baseline visit (ct scan, mri).
boolean
C0023903 (UMLS CUI [1])
C0456389 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0456389 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0205292 (UMLS CUI [3,3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Orthotopic liver transplant Due to Hepatitis B
Item
patients requiring an olt (orthotopic liver transplant)due to fulminant hepatitis b
boolean
C0400447 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
Orthotopic liver transplant | Liver graft Donor Hepatitis B surface antigen positive
Item
olt patients receiving a liver graft from a donor that is positive for hbsag
boolean
C0400447 (UMLS CUI [1])
C1720613 (UMLS CUI [2,1])
C0013018 (UMLS CUI [2,2])
C0149709 (UMLS CUI [2,3])
Interferon prior to Transplantation
Item
patients using interferon pre-transplant (as interferon cannot be used post-transplant)
boolean
C3652465 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Immunoglobulin A deficiency
Item
history of iga (immunoglobulin a) deficiency
boolean
C0162538 (UMLS CUI [1])
Hypersensitivity Blood product
Item
history of hypersensitivity to blood products.
boolean
C0020517 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis C virus Positive
Item
hiv or hcv positive
boolean
C0019699 (UMLS CUI [1])
C0220847 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Investigational New Drugs | Study Subject Participation Status | Exception Quality of life Clinical Trials | Exception Repository Clinical Trials
Item
use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0034380 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3847505 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
Pregnancy | Pregnancy, Planned
Item
pregnancy or planned pregnancy during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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