ID

15243

Description

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

Link

https://clinicaltrials.gov/show/NCT02304315

Keywords

Versions (1)
  1. 5/23/16 5/23/16 -
Uploaded on

May 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B Infection NCT02304315

English

Eligibility Hepatitis B Infection NCT02304315

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
given written informed consent
Description

Informed consent

Data type

boolean

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

Age

Data type

boolean

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

Hepatitis B Transplantation of liver Expected

Data type

boolean

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

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
Exclusion Criteria
Description

Exclusion Criteria

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

Study Subject Participation Status

Data type

boolean

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

Repeat Surgery Scheduled Transplantation of liver

Data type

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
Description

Coinfection Hepatitis A Virus | HCV coinfection | Coinfection HIV

Data type

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
Description

Malignant Neoplasms | Primary malignant neoplasm of liver

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

anaphylaxis Investigational New Drugs Pharmaceutical Excipient

Data type

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
Description

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

Data type

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
Description

Immunoglobulins Other

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

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
Description

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

Data type

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
Description

Substance Use Disorders

Data type

boolean

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

Disease Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
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Similar models

Eligibility Hepatitis B Infection NCT02304315

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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