ID

39633

Beschreibung

Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients; ODM derived from: https://clinicaltrials.gov/show/NCT01292824

Link

https://clinicaltrials.gov/show/NCT01292824

Stichworte

Versionen (1)
  1. 06.02.20 06.02.20 -
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See clinicaltrials.gov

Hochgeladen am

6. Februar 2020

DOI

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Eligibility Hepatitis C NCT01292824

Englisch

Eligibility Hepatitis C NCT01292824

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years old, ≤ 65 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
plasma hcv rna positive at time of listing for liver transplantation
Beschreibung

Plasma Hepatitis C RNA positive | Patient on waiting list Transplantation of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0855842
UMLS CUI [2,1]
C0422768
UMLS CUI [2,2]
C0023911
accepted for liver transplantation for any of:
Beschreibung

Patients Accepted Transplantation of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1272684
UMLS CUI [1,3]
C0023911
end-stage liver disease due to hcv infection
Beschreibung

End Stage Liver Disease Due to Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745744
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019196
end-stage liver disease due to hcv infection and alcohol related liver disease (ald)
Beschreibung

End Stage Liver Disease Due to Hepatitis C | Alcohol-related liver disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745744
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019196
UMLS CUI [2]
C0810031
hcc due to hcv
Beschreibung

Liver carcinoma Due to Hepatitis C virus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0220847
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
refusal or inability to give informed consent
Beschreibung

Informed Consent Refused | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
viral co-infection with either hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Beschreibung

HBV coinfection | Human immunodeficiency virus (HIV) coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
pregnancy or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women, of child-bearing potential, who are not willing to practice effective contraception
Beschreibung

Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
Beschreibung

Gender Sexually active Childbearing Potential | Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
any situation that in the investigator's opinion may interfere with optimal study participation
Beschreibung

Social situation Interferes with Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748872
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
participation in any clinical study of an investigational agent within 30 days of recruitment
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
transplantation with a donor organ from a hcv positive individual
Beschreibung

Transplantation | Organ donor Hepatitis C Virus Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0040732
UMLS CUI [2,1]
C0029206
UMLS CUI [2,2]
C4330254
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Ähnliche Modelle

Eligibility Hepatitis C NCT01292824

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years old, ≤ 65 years old
boolean
C0001779 (UMLS CUI [1])
Plasma Hepatitis C RNA positive | Patient on waiting list Transplantation of liver
Item
plasma hcv rna positive at time of listing for liver transplantation
boolean
C0032105 (UMLS CUI [1,1])
C0855842 (UMLS CUI [1,2])
C0422768 (UMLS CUI [2,1])
C0023911 (UMLS CUI [2,2])
Patients Accepted Transplantation of liver
Item
accepted for liver transplantation for any of:
boolean
C0030705 (UMLS CUI [1,1])
C1272684 (UMLS CUI [1,2])
C0023911 (UMLS CUI [1,3])
End Stage Liver Disease Due to Hepatitis C
Item
end-stage liver disease due to hcv infection
boolean
C0745744 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
End Stage Liver Disease Due to Hepatitis C | Alcohol-related liver disease
Item
end-stage liver disease due to hcv infection and alcohol related liver disease (ald)
boolean
C0745744 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0810031 (UMLS CUI [2])
Liver carcinoma Due to Hepatitis C virus
Item
hcc due to hcv
boolean
C2239176 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Refused | Informed Consent Unable
Item
refusal or inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
HBV coinfection | Human immunodeficiency virus (HIV) coinfection
Item
viral co-infection with either hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
women, of child-bearing potential, who are not willing to practice effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Gender Sexually active Childbearing Potential | Contraceptive methods Unwilling
Item
men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Social situation Interferes with Study Subject Participation Status
Item
any situation that in the investigator's opinion may interfere with optimal study participation
boolean
C0748872 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any clinical study of an investigational agent within 30 days of recruitment
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Transplantation | Organ donor Hepatitis C Virus Positive
Item
transplantation with a donor organ from a hcv positive individual
boolean
C0040732 (UMLS CUI [1])
C0029206 (UMLS CUI [2,1])
C4330254 (UMLS CUI [2,2])
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