ID

41140

Description

Study on the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT02125071

Lien

https://clinicaltrials.gov/show/NCT02125071

Mots-clés

  1. 30/06/2020 30/06/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

30 juin 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Liver Cirrhosis NCT02125071

Eligibility Liver Cirrhosis NCT02125071

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female ≤18 years old
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
patients who understand the informed consent form and signed the form voluntarily
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
patients who underwent liver transplantation due to hbv related disease and will be treated for prevention of hepatitis b relapse after liver transplantation
Description

Transplantation of liver Due to Hepatitis B | Prophylactic treatment Hepatitis B Relapse | Status post Transplantation of liver

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023911
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019163
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0019163
UMLS CUI [2,3]
C0035020
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0023911
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
multi-organ recipient or reimplantation
Description

Recipient Organ multiple | Surgical Replantation

Type de données

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0439064
UMLS CUI [2]
C0035139
iga deficiency
Description

Immunoglobulin A deficiency

Type de données

boolean

Alias
UMLS CUI [1]
C0162538
serious nephropathy
Description

Kidney Disease Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205404
serious cardiovascular system failure within 6 months
Description

Cardiovascular system Failure Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0231174
UMLS CUI [1,3]
C0205404
ischemic or hemolytic anemia
Description

Anemia Ischemic | Anemia, Hemolytic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0475224
UMLS CUI [2]
C0002878
condition of immunosuppression and immunodeficiency
Description

Immunosuppression | Immunodeficiency

Type de données

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
hypersensitivity or allergic to blood products
Description

Hypersensitivity Blood product

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0456388
hiv or hcv positive
Description

HIV Seropositivity | Hepatitis C Virus Positive

Type de données

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C4330254
participation to other clinical trial within 3 months
Description

Study Subject Participation Status | Clinical Trial

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
those who the investigator determines inappropriate to participate
Description

Study Subject Participation Status Inappropriate

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788

Similar models

Eligibility Liver Cirrhosis NCT02125071

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female ≤18 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patients who understand the informed consent form and signed the form voluntarily
boolean
C0021430 (UMLS CUI [1])
Transplantation of liver Due to Hepatitis B | Prophylactic treatment Hepatitis B Relapse | Status post Transplantation of liver
Item
patients who underwent liver transplantation due to hbv related disease and will be treated for prevention of hepatitis b relapse after liver transplantation
boolean
C0023911 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0199176 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Recipient Organ multiple | Surgical Replantation
Item
multi-organ recipient or reimplantation
boolean
C1709854 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0035139 (UMLS CUI [2])
Immunoglobulin A deficiency
Item
iga deficiency
boolean
C0162538 (UMLS CUI [1])
Kidney Disease Serious
Item
serious nephropathy
boolean
C0022658 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Cardiovascular system Failure Serious
Item
serious cardiovascular system failure within 6 months
boolean
C0007226 (UMLS CUI [1,1])
C0231174 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Anemia Ischemic | Anemia, Hemolytic
Item
ischemic or hemolytic anemia
boolean
C0002871 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0002878 (UMLS CUI [2])
Immunosuppression | Immunodeficiency
Item
condition of immunosuppression and immunodeficiency
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Hypersensitivity Blood product
Item
hypersensitivity or allergic to blood products
boolean
C0020517 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis C Virus Positive
Item
hiv or hcv positive
boolean
C0019699 (UMLS CUI [1])
C4330254 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial
Item
participation to other clinical trial within 3 months
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status Inappropriate
Item
those who the investigator determines inappropriate to participate
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])

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