ID

39551

Description

Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders; ODM derived from: https://clinicaltrials.gov/show/NCT01126853

Lien

https://clinicaltrials.gov/show/NCT01126853

Mots-clés

Versions (1)
  1. 27/01/2020 27/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 janvier 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01126853

Anglais

Eligibility Hepatitis B NCT01126853

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry.
Description

Comprehension Study Protocol | Protocol Compliance | Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
UMLS CUI [3]
C0021430
available for follow-up during the study period.
Description

Patient Available Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
has had at least two complete courses of monovalent hepatitis b vaccine, and has documented antihbs igg titers of <10miu/ml within 6 months of completion of the most recent course of vaccination.
Description

Course Quantity Hepatitis B vaccine | Hepatitis B Virus Surface Antibody Immunoglobulin G Titer

Type de données

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2066344
UMLS CUI [2,1]
C0369334
UMLS CUI [2,2]
C0020852
UMLS CUI [2,3]
C0475208
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergic to any components of the vaccine.
Description

Hypersensitivity Vaccine Component

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
previous serious adverse events associated with the hepatitis b vaccine
Description

Serious Adverse Event Associated with Hepatitis B vaccine

Type de données

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C2066344
received one or more doses of twinrix in the past
Description

Twinrix Dose Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0593953
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
chronic hepatitis b infection, defined as ever having had a positive hbsag, hbcab or hepb rna test
Description

Hepatitis B, Chronic | Hepatitis B surface antigen positive | Hepatitis B core antibody positive | Hepatitis B Virus RNA Test Positive

Type de données

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0262506
UMLS CUI [4,1]
C0019169
UMLS CUI [4,2]
C0035668
UMLS CUI [4,3]
C0039593
UMLS CUI [4,4]
C1514241
pregnant, or planning to become pregnant during the study period.
Description

Pregnancy | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
received dose of hepatitis b immune globulin, or immune globulin, in last 6 months
Description

Hepatitis B immune globulin Dose | Immunoglobulin Dose

Type de données

boolean

Alias
UMLS CUI [1,1]
C0062525
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0021027
UMLS CUI [2,2]
C0178602
immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination, including:
Description

Immunocompromised patient | Therapy Reducing Effectiveness Vaccination

Type de données

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0392756
UMLS CUI [2,3]
C1280519
UMLS CUI [2,4]
C0042196
1. hiv infection;
Description

HIV Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
2. lymphoma, multiple myeloma, leukemia or other blood dyscrasia;
Description

Lymphoma | Multiple Myeloma | Leukemia | Hematological Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0024299
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0023418
UMLS CUI [4]
C0018939
3. systemic lupus erythematosis or other connective tissue disorder;
Description

Lupus Erythematosus, Systemic | Connective Tissue Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0009782
4. renal failure (baseline serum creatinine >150um, or requires dialysis);
Description

Kidney Failure | Creatinine measurement, serum | Requirement Dialysis

Type de données

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0011946
5. nephrotic syndrome;
Description

Nephrotic Syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C0027726
6. active neoplastic disease (except localized skin cancer);
Description

Neoplastic disease | Exception Localised skin tumour

Type de données

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0849656
7. any requirement for corticosteroids >20mg/day for >1 week in the six months prior to randomization;
Description

Requirement Adrenal Cortex Hormones U/day

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0456683
8. cytotoxic therapy (e.g. chemotherapy for cancer) received within the six months prior to randomization
Description

Cytotoxic Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0677881
9. radiation therapy received in the six months prior to randomization;
Description

Therapeutic radiology procedure

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
10. hemoglobinopathy;
Description

Hemoglobinopathy

Type de données

boolean

Alias
UMLS CUI [1]
C0019045
11. any immunodeficiency disorder; or
Description

Immunodeficiency disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0021051
12. prior solid organ or allogeneic stem cell or bone marrow transplant.
Description

Solid organ transplant | Allogeneic hematopoietic stem cell transplant | Bone Marrow Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0730400
UMLS CUI [2]
C4255274
UMLS CUI [3]
C0005961
plans to receive cytotoxic therapy or radiation therapy during the study period.
Description

Cytotoxic Therapy Planned | Therapeutic radiology procedure Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Hepatitis B NCT01126853

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Comprehension Study Protocol | Protocol Compliance | Informed Consent
Item
have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Patient Available Follow-up
Item
available for follow-up during the study period.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Course Quantity Hepatitis B vaccine | Hepatitis B Virus Surface Antibody Immunoglobulin G Titer
Item
has had at least two complete courses of monovalent hepatitis b vaccine, and has documented antihbs igg titers of <10miu/ml within 6 months of completion of the most recent course of vaccination.
boolean
C0750729 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2066344 (UMLS CUI [1,3])
C0369334 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C0475208 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Vaccine Component
Item
allergic to any components of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Serious Adverse Event Associated with Hepatitis B vaccine
Item
previous serious adverse events associated with the hepatitis b vaccine
boolean
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C2066344 (UMLS CUI [1,3])
Twinrix Dose Quantity
Item
received one or more doses of twinrix in the past
boolean
C0593953 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hepatitis B, Chronic | Hepatitis B surface antigen positive | Hepatitis B core antibody positive | Hepatitis B Virus RNA Test Positive
Item
chronic hepatitis b infection, defined as ever having had a positive hbsag, hbcab or hepb rna test
boolean
C0524909 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0262506 (UMLS CUI [3])
C0019169 (UMLS CUI [4,1])
C0035668 (UMLS CUI [4,2])
C0039593 (UMLS CUI [4,3])
C1514241 (UMLS CUI [4,4])
Pregnancy | Pregnancy, Planned
Item
pregnant, or planning to become pregnant during the study period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Hepatitis B immune globulin Dose | Immunoglobulin Dose
Item
received dose of hepatitis b immune globulin, or immune globulin, in last 6 months
boolean
C0062525 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0021027 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Immunocompromised patient | Therapy Reducing Effectiveness Vaccination
Item
immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination, including:
boolean
C0085393 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
HIV Infection
Item
1. hiv infection;
boolean
C0019693 (UMLS CUI [1])
Lymphoma | Multiple Myeloma | Leukemia | Hematological Disease
Item
2. lymphoma, multiple myeloma, leukemia or other blood dyscrasia;
boolean
C0024299 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0023418 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
Lupus Erythematosus, Systemic | Connective Tissue Disease
Item
3. systemic lupus erythematosis or other connective tissue disorder;
boolean
C0024141 (UMLS CUI [1])
C0009782 (UMLS CUI [2])
Kidney Failure | Creatinine measurement, serum | Requirement Dialysis
Item
4. renal failure (baseline serum creatinine >150um, or requires dialysis);
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0011946 (UMLS CUI [3,2])
Nephrotic Syndrome
Item
5. nephrotic syndrome;
boolean
C0027726 (UMLS CUI [1])
Neoplastic disease | Exception Localised skin tumour
Item
6. active neoplastic disease (except localized skin cancer);
boolean
C1882062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0849656 (UMLS CUI [2,2])
Requirement Adrenal Cortex Hormones U/day
Item
7. any requirement for corticosteroids >20mg/day for >1 week in the six months prior to randomization;
boolean
C1514873 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Cytotoxic Therapy
Item
8. cytotoxic therapy (e.g. chemotherapy for cancer) received within the six months prior to randomization
boolean
C0677881 (UMLS CUI [1])
Therapeutic radiology procedure
Item
9. radiation therapy received in the six months prior to randomization;
boolean
C1522449 (UMLS CUI [1])
Hemoglobinopathy
Item
10. hemoglobinopathy;
boolean
C0019045 (UMLS CUI [1])
Immunodeficiency disorder
Item
11. any immunodeficiency disorder; or
boolean
C0021051 (UMLS CUI [1])
Solid organ transplant | Allogeneic hematopoietic stem cell transplant | Bone Marrow Transplantation
Item
12. prior solid organ or allogeneic stem cell or bone marrow transplant.
boolean
C0730400 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
C0005961 (UMLS CUI [3])
Cytotoxic Therapy Planned | Therapeutic radiology procedure Planned
Item
plans to receive cytotoxic therapy or radiation therapy during the study period.
boolean
C0677881 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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