ID

25161

Description

Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00582738

Link

https://clinicaltrials.gov/show/NCT00582738

Keywords

Versions (2)
  1. 8/28/17 8/28/17 -
  2. 8/28/17 8/28/17 -
Uploaded on

August 28, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Recurrent Hepatitis C NCT00582738

English

Eligibility Recurrent Hepatitis C NCT00582738

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients 18 - 65 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
recipients of deceased or living donors
Description

Recipient Cadaver donor | Recipient Living Donors

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0524354
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C0348050
patients who had undergone primary liver transplantation at least 6 months before enrolment
Description

Transplantation of liver Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0023911
UMLS CUI [1,2]
C0205225
recurrent hepatitis c viral infection and histologically confirmed liver fibrosis (stage i-iv in the ishak-knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment
Description

Hepatitis C recurrent | Liver Fibrosis Ishak Score | Liver Fibrosis Knodell Score

Data type

boolean

Alias
UMLS CUI [1]
C2938989
UMLS CUI [2,1]
C0239946
UMLS CUI [2,2]
C2986945
UMLS CUI [3,1]
C0239946
UMLS CUI [3,2]
C3898641
patients receiving tacrolimus or cyclosporine micro-emulsion with or without -
Description

Tacrolimus | cyclosporine microemulsion

Data type

boolean

Alias
UMLS CUI [1]
C0085149
UMLS CUI [2]
C1577018
mycophenolic acid (mpa), with or without steroids.
Description

Mycophenolic Acid | Steroids

Data type

boolean

Alias
UMLS CUI [1]
C0026933
UMLS CUI [2]
C0038317
absence of acute rejection episodes within the previous 6 months to the date of enrolment
Description

Rejection episode Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0877542
UMLS CUI [1,2]
C0332197
patient in whom an allograft biopsy will not be contraindicated
Description

Allograft Biopsy | Medical contraindication Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0450127
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months
Description

Informed Consent | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2348568
patients with hepatocellular carcinoma (hcc) within the university california, san francisco (ucsf) criteria and no recurrence for at least 18 months after olt.
Description

Liver carcinoma | Recurrence Absent

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0034897
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recipients of multiple organ transplants or patients who have undergone retransplantation
Description

Recipient Organ Transplant multiple | Retransplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0029216
UMLS CUI [1,3]
C0439064
UMLS CUI [2]
C0597409
current biliary complications
Description

Complications biliary

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0521378
history of drug or alcohol abuse within 1 year before enrolment
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
patients treated with anti-hepatitis c virus treatment at the time of enrollment or within the previous month to the date of enrolment
Description

Therapeutic procedure Against Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0220847
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Description

HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
patients with leukocyte count (wbc) < 3000/mm3, platelet count < 75000/mm3 or hemoglobin (hb) < 8 g/dl
Description

White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
patients with proteinuria >1g/24 hours
Description

Proteinuria

Data type

boolean

Alias
UMLS CUI [1]
C0033687
patient with a current severe systemic infection
Description

Severe Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C1719672
other protocol defined inclusion/exclusion criteria may apply.
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Recurrent Hepatitis C NCT00582738

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients 18 - 65 years of age
boolean
C0001779 (UMLS CUI [1])
Recipient Cadaver donor | Recipient Living Donors
Item
recipients of deceased or living donors
boolean
C1709854 (UMLS CUI [1,1])
C0524354 (UMLS CUI [1,2])
C1709854 (UMLS CUI [2,1])
C0348050 (UMLS CUI [2,2])
Transplantation of liver Primary
Item
patients who had undergone primary liver transplantation at least 6 months before enrolment
boolean
C0023911 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Hepatitis C recurrent | Liver Fibrosis Ishak Score | Liver Fibrosis Knodell Score
Item
recurrent hepatitis c viral infection and histologically confirmed liver fibrosis (stage i-iv in the ishak-knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment
boolean
C2938989 (UMLS CUI [1])
C0239946 (UMLS CUI [2,1])
C2986945 (UMLS CUI [2,2])
C0239946 (UMLS CUI [3,1])
C3898641 (UMLS CUI [3,2])
Tacrolimus | cyclosporine microemulsion
Item
patients receiving tacrolimus or cyclosporine micro-emulsion with or without -
boolean
C0085149 (UMLS CUI [1])
C1577018 (UMLS CUI [2])
Mycophenolic Acid | Steroids
Item
mycophenolic acid (mpa), with or without steroids.
boolean
C0026933 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
Rejection episode Absent
Item
absence of acute rejection episodes within the previous 6 months to the date of enrolment
boolean
C0877542 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Allograft Biopsy | Medical contraindication Absent
Item
patient in whom an allograft biopsy will not be contraindicated
boolean
C0450127 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent | Study Subject Participation Status
Item
patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months
boolean
C0021430 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Liver carcinoma | Recurrence Absent
Item
patients with hepatocellular carcinoma (hcc) within the university california, san francisco (ucsf) criteria and no recurrence for at least 18 months after olt.
boolean
C2239176 (UMLS CUI [1])
C0034897 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Recipient Organ Transplant multiple | Retransplantation
Item
recipients of multiple organ transplants or patients who have undergone retransplantation
boolean
C1709854 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0597409 (UMLS CUI [2])
Complications biliary
Item
current biliary complications
boolean
C0009566 (UMLS CUI [1,1])
C0521378 (UMLS CUI [1,2])
Substance Use Disorders
Item
history of drug or alcohol abuse within 1 year before enrolment
boolean
C0038586 (UMLS CUI [1])
Therapeutic procedure Against Hepatitis C virus
Item
patients treated with anti-hepatitis c virus treatment at the time of enrollment or within the previous month to the date of enrolment
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
patients with leukocyte count (wbc) < 3000/mm3, platelet count < 75000/mm3 or hemoglobin (hb) < 8 g/dl
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Proteinuria
Item
patients with proteinuria >1g/24 hours
boolean
C0033687 (UMLS CUI [1])
Severe Sepsis
Item
patient with a current severe systemic infection
boolean
C1719672 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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