ID

39258

Beschreibung

Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT01195246

Link

https://clinicaltrials.gov/show/NCT01195246

Stichworte

Versionen (1)
  1. 13.12.19 13.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. Dezember 2019

DOI

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Eligibility End Stage Renal Disease NCT01195246

Englisch

Eligibility End Stage Renal Disease NCT01195246

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
has loss of renal function and is receiving hemodialysis treatments
Beschreibung

Chronic Kidney Disease | Hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0019004
is not seroprotected against hepatitis b (has anti-hbs < 10 miu/ml)
Beschreibung

Infection protection Absent Hepatitis B | Hepatitis B surface antibody measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0150259
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0019163
UMLS CUI [2]
C0201478
in the opinion of the investigator, is clinically stable
Beschreibung

Stable status Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
be serum negative for hbsag, anti-hepatitis b core antigen (hbc), hepatitis c virus (hcv), and hiv
Beschreibung

Seronegative Hepatitis B Surface Antigens | Seronegative Antibody to hepatitis B core antigen | Seronegative Hepatitis C virus | Seronegative HIV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521144
UMLS CUI [1,2]
C0019168
UMLS CUI [2,1]
C0521144
UMLS CUI [2,2]
C0312631
UMLS CUI [3,1]
C0521144
UMLS CUI [3,2]
C0220847
UMLS CUI [4,1]
C0521144
UMLS CUI [4,2]
C0019682
is not scheduled to undergo a kidney transplant during the study period
Beschreibung

Absence Treatment schedule Kidney Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0040808
UMLS CUI [1,3]
C0022671
if female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study.
Beschreibung

Childbearing Potential Contraceptive methods | Female Sterilization | Pregnancy Absent | Breast Feeding Absent | Contraceptive methods Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
if female, is pregnant, breastfeeding, or planning a pregnancy;
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
has a history of or is at high risk for recent exposure to hbv, hcv, or hiv;
Beschreibung

Exposure to Hepatitis B Virus | Exposure to Hepatitis C virus | Exposure to HIV | High risk of Exposure to Hepatitis B Virus | High risk of Exposure to Hepatitis C virus | High risk of Exposure to HIV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0019169
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0220847
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0019682
UMLS CUI [4,1]
C0332167
UMLS CUI [4,2]
C0332157
UMLS CUI [4,3]
C0019169
UMLS CUI [5,1]
C0332167
UMLS CUI [5,2]
C0332157
UMLS CUI [5,3]
C0220847
UMLS CUI [6,1]
C0332167
UMLS CUI [6,2]
C0332157
UMLS CUI [6,3]
C0019682
has known history of autoimmune disease;
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
has history of sensitivity to any component of study vaccines;
Beschreibung

Hypersensitivity Component Clinical Trial Vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0042210
has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results;
Beschreibung

Condition Interferes with Compliance | Exception Kidney Disease | Substance Use Disorder Interferes with Compliance | Condition Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1321605
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0022658
UMLS CUI [3,1]
C0038586
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1321605
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0683954
UMLS CUI [5,1]
C0038586
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0683954
is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
Beschreibung

Chemotherapy | Chemotherapy Expected | Malignant Neoplasm | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1517001
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
has uncontrolled diabetes;
Beschreibung

Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
has received a kidney transplant previously that is still functioning and requires anti-rejection medication;
Beschreibung

Kidney Transplantation Requirement Therapeutic immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
Beschreibung

Blood product Received | Immunoglobulin Received | Requirement Blood Product Transfusion Probably

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C1514756
UMLS CUI [2,1]
C0021027
UMLS CUI [2,2]
C1514756
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0005841
UMLS CUI [3,3]
C0750492
has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (g-csf) or granulocyte-macrophage colony stimulating factor (gm-csf); any other investigational medicinal agent;
Beschreibung

Intravenous infusion of iron | Inactivated Vaccine Virus | Inactivated Vaccines Bacterial | Attenuated Live Virus Vaccine | Attenuated Bacteria Vaccine | CORTICOSTEROIDS FOR SYSTEMIC USE | Immunomodulators | Immunosuppressive Agents | Exception Inhaled steroids | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C4305398
UMLS CUI [2,1]
C0042776
UMLS CUI [2,2]
C0042212
UMLS CUI [3,1]
C0042212
UMLS CUI [3,2]
C0521009
UMLS CUI [4]
C1516086
UMLS CUI [5]
C1879753
UMLS CUI [6]
C3653708
UMLS CUI [7]
C1527392
UMLS CUI [8]
C0021081
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C2065041
UMLS CUI [10]
C0079459
UMLS CUI [11]
C0079460
UMLS CUI [12]
C0013230
at any time: an injection of deoxyribonucleic acid (dna) plasmids or oligonucleotides; investigational or intradermal hepatitis b vaccine.
Beschreibung

Plasmid Injection | Oligonucleotide Injection | Hepatitis B Vaccines Investigational | Hepatitis B Vaccines Intradermal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032136
UMLS CUI [1,2]
C1533685
UMLS CUI [2,1]
C0028953
UMLS CUI [2,2]
C1533685
UMLS CUI [3,1]
C2240392
UMLS CUI [3,2]
C1517586
UMLS CUI [4,1]
C2240392
UMLS CUI [4,2]
C1522475
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Ähnliche Modelle

Eligibility End Stage Renal Disease NCT01195246

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic Kidney Disease | Hemodialysis
Item
has loss of renal function and is receiving hemodialysis treatments
boolean
C1561643 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
Infection protection Absent Hepatitis B | Hepatitis B surface antibody measurement
Item
is not seroprotected against hepatitis b (has anti-hbs < 10 miu/ml)
boolean
C0150259 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0201478 (UMLS CUI [2])
Stable status Clinical
Item
in the opinion of the investigator, is clinically stable
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Seronegative Hepatitis B Surface Antigens | Seronegative Antibody to hepatitis B core antigen | Seronegative Hepatitis C virus | Seronegative HIV
Item
be serum negative for hbsag, anti-hepatitis b core antigen (hbc), hepatitis c virus (hcv), and hiv
boolean
C0521144 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C0521144 (UMLS CUI [2,1])
C0312631 (UMLS CUI [2,2])
C0521144 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C0521144 (UMLS CUI [4,1])
C0019682 (UMLS CUI [4,2])
Absence Treatment schedule Kidney Transplantation
Item
is not scheduled to undergo a kidney transplant during the study period
boolean
C0332197 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0022671 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Female Sterilization | Pregnancy Absent | Breast Feeding Absent | Contraceptive methods Quantity
Item
if female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
if female, is pregnant, breastfeeding, or planning a pregnancy;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Exposure to Hepatitis B Virus | Exposure to Hepatitis C virus | Exposure to HIV | High risk of Exposure to Hepatitis B Virus | High risk of Exposure to Hepatitis C virus | High risk of Exposure to HIV
Item
has a history of or is at high risk for recent exposure to hbv, hcv, or hiv;
boolean
C0332157 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0019682 (UMLS CUI [3,2])
C0332167 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C0019169 (UMLS CUI [4,3])
C0332167 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
C0220847 (UMLS CUI [5,3])
C0332167 (UMLS CUI [6,1])
C0332157 (UMLS CUI [6,2])
C0019682 (UMLS CUI [6,3])
Autoimmune Disease
Item
has known history of autoimmune disease;
boolean
C0004364 (UMLS CUI [1])
Hypersensitivity Component Clinical Trial Vaccines
Item
has history of sensitivity to any component of study vaccines;
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Condition Interferes with Compliance | Exception Kidney Disease | Substance Use Disorder Interferes with Compliance | Condition Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results
Item
has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results;
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0022658 (UMLS CUI [2,2])
C0038586 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
Chemotherapy | Chemotherapy Expected | Malignant Neoplasm | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma
Item
is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
boolean
C0392920 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
Diabetic - poor control
Item
has uncontrolled diabetes;
boolean
C0421258 (UMLS CUI [1])
Kidney Transplantation Requirement Therapeutic immunosuppression
Item
has received a kidney transplant previously that is still functioning and requires anti-rejection medication;
boolean
C0022671 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Blood product Received | Immunoglobulin Received | Requirement Blood Product Transfusion Probably
Item
has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
boolean
C0456388 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0021027 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0005841 (UMLS CUI [3,2])
C0750492 (UMLS CUI [3,3])
Intravenous infusion of iron | Inactivated Vaccine Virus | Inactivated Vaccines Bacterial | Attenuated Live Virus Vaccine | Attenuated Bacteria Vaccine | CORTICOSTEROIDS FOR SYSTEMIC USE | Immunomodulators | Immunosuppressive Agents | Exception Inhaled steroids | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor | Investigational New Drugs
Item
has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (g-csf) or granulocyte-macrophage colony stimulating factor (gm-csf); any other investigational medicinal agent;
boolean
C4305398 (UMLS CUI [1])
C0042776 (UMLS CUI [2,1])
C0042212 (UMLS CUI [2,2])
C0042212 (UMLS CUI [3,1])
C0521009 (UMLS CUI [3,2])
C1516086 (UMLS CUI [4])
C1879753 (UMLS CUI [5])
C3653708 (UMLS CUI [6])
C1527392 (UMLS CUI [7])
C0021081 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C2065041 (UMLS CUI [9,2])
C0079459 (UMLS CUI [10])
C0079460 (UMLS CUI [11])
C0013230 (UMLS CUI [12])
Plasmid Injection | Oligonucleotide Injection | Hepatitis B Vaccines Investigational | Hepatitis B Vaccines Intradermal
Item
at any time: an injection of deoxyribonucleic acid (dna) plasmids or oligonucleotides; investigational or intradermal hepatitis b vaccine.
boolean
C0032136 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0028953 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C2240392 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C2240392 (UMLS CUI [4,1])
C1522475 (UMLS CUI [4,2])
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