ID

39560

Description

Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis; ODM derived from: https://clinicaltrials.gov/show/NCT01884415

Link

https://clinicaltrials.gov/show/NCT01884415

Keywords

Versions (1)
  1. 1/28/20 1/28/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 28, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01884415

English

Eligibility Hepatitis B NCT01884415

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. cirrhotic patients, potential candidates for liver transplantation, with indication to hbv vaccination (hbsag negative and anti-hbs negative).
Description

Patients Cirrhotic | Patients Appropriate Transplantation of liver | Indication Hepatitis B Virus Vaccination | Hepatitis B surface antigen negative | Hepatitis B surface antibody negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439686
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0023911
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0019169
UMLS CUI [3,3]
C0042196
UMLS CUI [4]
C0919711
UMLS CUI [5]
C0744842
2. patients under treatment with hbvaxpro® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
Description

Hepatitis B vaccine Specified | Other Coding | Response Lacking | Status post Vaccination Dose Intramuscular

Data type

boolean

Alias
UMLS CUI [1,1]
C2066344
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0442117
3. patients over 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. negative pregnancy test.
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
5. patients who have given their consent to participate in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. absolute contraindication to hbv vaccine.
Description

Medical contraindication Hepatitis B Virus Vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0019169
UMLS CUI [1,3]
C0042210
2. medical history of allergy to any component of the vaccine.
Description

Hypersensitivity Vaccine Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
3. chronic renal failure on hemodialysis.
Description

Kidney Failure, Chronic | Hemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0019004
4. presence of antibodies against human immunodeficiency virus.
Description

HIV Antibodies Present

Data type

boolean

Alias
UMLS CUI [1,1]
C0019683
UMLS CUI [1,2]
C0150312
5. patients with seroconversion (anti-hbs > 10 iu /ml) after the first three doses of vaccine.
Description

Seroconversion | Hepatitis B Virus Surface Antibody | Status post Administration of vaccine Dose Quantity

Data type

boolean

Alias
UMLS CUI [1]
C4042908
UMLS CUI [2]
C0369334
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2368628
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C1265611
6. lack of consent to participate in the study.
Description

Informed Consent Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Hepatitis B NCT01884415

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Cirrhotic | Patients Appropriate Transplantation of liver | Indication Hepatitis B Virus Vaccination | Hepatitis B surface antigen negative | Hepatitis B surface antibody negative
Item
1. cirrhotic patients, potential candidates for liver transplantation, with indication to hbv vaccination (hbsag negative and anti-hbs negative).
boolean
C0030705 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0023911 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0019169 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
C0919711 (UMLS CUI [4])
C0744842 (UMLS CUI [5])
Hepatitis B vaccine Specified | Other Coding | Response Lacking | Status post Vaccination Dose Intramuscular
Item
2. patients under treatment with hbvaxpro® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
boolean
C2066344 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0442117 (UMLS CUI [4,4])
Age
Item
3. patients over 18 years old.
boolean
C0001779 (UMLS CUI [1])
Pregnancy test negative
Item
4. negative pregnancy test.
boolean
C0427780 (UMLS CUI [1])
Informed Consent
Item
5. patients who have given their consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Hepatitis B Virus Vaccine
Item
1. absolute contraindication to hbv vaccine.
boolean
C1301624 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Hypersensitivity Vaccine Component
Item
2. medical history of allergy to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Kidney Failure, Chronic | Hemodialysis
Item
3. chronic renal failure on hemodialysis.
boolean
C0022661 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
HIV Antibodies Present
Item
4. presence of antibodies against human immunodeficiency virus.
boolean
C0019683 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Seroconversion | Hepatitis B Virus Surface Antibody | Status post Administration of vaccine Dose Quantity
Item
5. patients with seroconversion (anti-hbs > 10 iu /ml) after the first three doses of vaccine.
boolean
C4042908 (UMLS CUI [1])
C0369334 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C2368628 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Informed Consent Lacking
Item
6. lack of consent to participate in the study.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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