ID

15243

Beschreibung

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

Stichworte

Versionen (1)
  1. 23.05.16 23.05.16 -
Hochgeladen am

23. Mai 2016

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis B Infection NCT02304315

Englisch

Eligibility Hepatitis B Infection NCT02304315

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
given written informed consent
Beschreibung

Informed consent

Datentyp

boolean

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

Age

Datentyp

boolean

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

Hepatitis B Transplantation of liver Expected

Datentyp

boolean

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

Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Study Subject Participation Status

Datentyp

boolean

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

Repeat Surgery Scheduled Transplantation of liver

Datentyp

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
Beschreibung

Coinfection Hepatitis A Virus | HCV coinfection | Coinfection HIV

Datentyp

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
Beschreibung

Malignant Neoplasms | Primary malignant neoplasm of liver

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

anaphylaxis Investigational New Drugs Pharmaceutical Excipient

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Immunoglobulins Other

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Substance Use Disorders

Datentyp

boolean

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

Disease Study Subject Participation Status Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
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Ähnliche Modelle

Eligibility Hepatitis B Infection NCT02304315

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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