ID

15243

Beskrivning

A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients; ODM derived from: https://clinicaltrials.gov/show/NCT02304315

Länk

https://clinicaltrials.gov/show/NCT02304315

Nyckelord

Versioner (1)
  1. 2016-05-23 2016-05-23 -
Uppladdad den

23 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B Infection NCT02304315

Engelsk

Eligibility Hepatitis B Infection NCT02304315

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
given written informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
aged 19 - 65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
expected liver transplantation related to hepatitis b
Beskrivning

Hepatitis B Transplantation of liver Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0023911
UMLS CUI [1,3]
C1517001
positive hbsag
Beskrivning

Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients has participated in any other clinical trial within 30 days
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
patients who are scheduled re-operation for liver transplantation
Beskrivning

Repeat Surgery Scheduled Transplantation of liver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035110
UMLS CUI [1,2]
C0205539
UMLS CUI [1,3]
C0023911
patients with are co-infected with hav, hcv or hiv
Beskrivning

Coinfection Hepatitis A Virus | HCV coinfection | Coinfection HIV

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0376325
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0019682
history of malignant tumor within 5 years except primary liver cancer
Beskrivning

Malignant Neoplasms | Primary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0024620
patients with moderate or severe renal disorder (serum creatinine > 1.5 x ulm) or anuria, acute renal failure or dialysis
Beskrivning

Moderate or Severe Renal Disease | Creatinine measurement, serum | Anuria | Kidney Failure, Acute | Dialysis procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C3829820
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0003460
UMLS CUI [4]
C0022660
UMLS CUI [5]
C0011946
patients who had experienced cardiovascular attack, myocardiac infarction, ptca or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months
Beskrivning

cardiovascular; attack | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Angina Pectoris | Cardiac Arrhythmia | Heart valve disease | Cerebral Infarction | Cerebral Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C1385306
UMLS CUI [2]
C0027051
UMLS CUI [3]
C2936173
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0002962
UMLS CUI [6]
C0003811
UMLS CUI [7]
C0018824
UMLS CUI [8]
C0007785
UMLS CUI [9]
C2937358
history of anaphylaxis against active ingredient or excipients of study drug
Beskrivning

anaphylaxis Investigational New Drugs Pharmaceutical Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0015237
patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months
Beskrivning

Attenuated Vaccines Parenteral Vaccinated | Measles Vaccine | Mumps Vaccine | Rubella virus vaccine | Cholera Vaccine | Chickenpox Vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042211
UMLS CUI [1,2]
C1518896
UMLS CUI [1,3]
C1519885
UMLS CUI [2]
C0025010
UMLS CUI [3]
C0026782
UMLS CUI [4]
C0035923
UMLS CUI [5]
C0008359
UMLS CUI [6]
C0078048
patients who had been treated with any other immuno globulin within 3 months
Beskrivning

Immunoglobulins Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0205394
pregnant or breast-feeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study
Beskrivning

Childbearing Potential Unwilling Contraceptive methods | Female Condom | Intrauterine Devices | Contraceptives, Oral, Hormonal | Vasectomy Sexual Partners Males

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0221829
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0009907
UMLS CUI [5,1]
C0042387
UMLS CUI [5,2]
C0036911
UMLS CUI [5,3]
C0086582
alcohol or drug abuse within 6 months
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study
Beskrivning

Disease Study Subject Participation Status Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
Tillbaka till toppen

Similar models

Eligibility Hepatitis B Infection NCT02304315

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
given written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
aged 19 - 65 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B Transplantation of liver Expected
Item
expected liver transplantation related to hepatitis b
boolean
C0019163 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Hepatitis B surface antigen positive
Item
positive hbsag
boolean
C0149709 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
patients has participated in any other clinical trial within 30 days
boolean
C2348568 (UMLS CUI [1])
Repeat Surgery Scheduled Transplantation of liver
Item
patients who are scheduled re-operation for liver transplantation
boolean
C0035110 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0023911 (UMLS CUI [1,3])
Coinfection Hepatitis A Virus | HCV coinfection | Coinfection HIV
Item
patients with are co-infected with hav, hcv or hiv
boolean
C0275524 (UMLS CUI [1,1])
C0376325 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0019682 (UMLS CUI [3,2])
Malignant Neoplasms | Primary malignant neoplasm of liver
Item
history of malignant tumor within 5 years except primary liver cancer
boolean
C0006826 (UMLS CUI [1])
C0024620 (UMLS CUI [2])
Moderate or Severe Renal Disease | Creatinine measurement, serum | Anuria | Kidney Failure, Acute | Dialysis procedure
Item
patients with moderate or severe renal disorder (serum creatinine > 1.5 x ulm) or anuria, acute renal failure or dialysis
boolean
C3829820 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0003460 (UMLS CUI [3])
C0022660 (UMLS CUI [4])
C0011946 (UMLS CUI [5])
cardiovascular; attack | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Angina Pectoris | Cardiac Arrhythmia | Heart valve disease | Cerebral Infarction | Cerebral Hemorrhage
Item
patients who had experienced cardiovascular attack, myocardiac infarction, ptca or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months
boolean
C1385306 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C2936173 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0018824 (UMLS CUI [7])
C0007785 (UMLS CUI [8])
C2937358 (UMLS CUI [9])
anaphylaxis Investigational New Drugs Pharmaceutical Excipient
Item
history of anaphylaxis against active ingredient or excipients of study drug
boolean
C0002792 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
Attenuated Vaccines Parenteral Vaccinated | Measles Vaccine | Mumps Vaccine | Rubella virus vaccine | Cholera Vaccine | Chickenpox Vaccine
Item
patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months
boolean
C0042211 (UMLS CUI [1,1])
C1518896 (UMLS CUI [1,2])
C1519885 (UMLS CUI [1,3])
C0025010 (UMLS CUI [2])
C0026782 (UMLS CUI [3])
C0035923 (UMLS CUI [4])
C0008359 (UMLS CUI [5])
C0078048 (UMLS CUI [6])
Immunoglobulins Other
Item
patients who had been treated with any other immuno globulin within 3 months
boolean
C0021027 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Unwilling Contraceptive methods | Female Condom | Intrauterine Devices | Contraceptives, Oral, Hormonal | Vasectomy Sexual Partners Males
Item
women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study
boolean
C3831118 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0221829 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0009907 (UMLS CUI [4])
C0042387 (UMLS CUI [5,1])
C0036911 (UMLS CUI [5,2])
C0086582 (UMLS CUI [5,3])
Substance Use Disorders
Item
alcohol or drug abuse within 6 months
boolean
C0038586 (UMLS CUI [1])
Disease Study Subject Participation Status Limited
Item
patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Tillbaka till toppen 

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