ID

29715

Description

Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00938860

Link

https://clinicaltrials.gov/show/NCT00938860

Keywords

Versions (1)
  1. 4/15/18 4/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C NCT00938860

English

Eligibility Hepatitis C NCT00938860

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
liver transplantation performed at least 6 months and up to 5 years prior randomization and due to hcv cirrhosis, with or without pre-transplant hepatocellular carcinoma (hcc) within milan or ucsf criteria
Description

Transplantation of liver | Etiology Cirrhosis due to hepatitis C | Liver carcinoma Pre Transplant | Absence Liver carcinoma Pre Transplant

Data type

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C2075271
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C0040732
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2239176
UMLS CUI [4,3]
C0332152
UMLS CUI [4,4]
C0040732
immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization
Description

Therapeutic immunosuppression | Tacrolimus

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0085149
diagnosis of hcv genotypes 1 or 4 infection prior to transplantationconfirmed at screening
Description

Hepatitis C HCV genotype determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
indication of treatment with peg-ifn and ribavirin due to histological evidence of chronic hcv infection defined as a fibrosis stage equal or greater than 1 using the ishak-knodell scoring system (ik ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization.
Description

Indication PEGINTERFERON/RIBAVIRIN | Hepatitis C, Chronic | Fibrosis stage Ishak Score Biopsy of liver | Fibrosis stage Knodell Fibrosis Score Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1875630
UMLS CUI [2]
C0524910
UMLS CUI [3,1]
C1954435
UMLS CUI [3,2]
C2986945
UMLS CUI [3,3]
C0193388
UMLS CUI [4,1]
C1954435
UMLS CUI [4,2]
C3898641
UMLS CUI [4,3]
C0193388
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum creatinine >150 μmol/l (1.6 7 mg/dl) or egfr < 50 ml/min (4-variable modification of diet in renal disease [mdrd cockcroft-gault formula])
Description

Creatinine measurement, serum | Estimated Glomerular Filtration Rate | Modification of diet in renal disease formula | Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C3811844
UMLS CUI [3]
C3839656
UMLS CUI [4]
C2924627
multi-organ transplant recipients
Description

Recipient Organ Transplant multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0029216
UMLS CUI [1,3]
C0439064
recent episode of steroid-treated acute rejection (ar) within 3 months prior to randomization, or >1 episode of steroid-treated ar in the last 6 months, or any number of steroid-resistant ar episodes in the last 6 months including evidence of chronic rejection or ductopenia
Description

Steroids Acute Rejection Episode | Steroids Acute Rejection Episode Quantity | Steroids Resistance | Acute Rejection Episode Quantity | Chronic graft rejection | Ductopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C3273245
UMLS CUI [1,3]
C0332189
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C3273245
UMLS CUI [2,3]
C0332189
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0013203
UMLS CUI [4,1]
C3273245
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C1265611
UMLS CUI [5]
C0301948
UMLS CUI [6]
C3830376
evidence of conditions that could cause graft dysfunction other than hcv infection
Description

Condition Causing Graft dysfunction | Exception Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1167870
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin <3.5g/dl or, total direct bilirubin >1.5mg/dl or, inr >1.5)
Description

Signs Decompensated liver disease | Ascites | Bleeding varices | Encephalopathy | Liver function deteriorating | Albumin measurement | Bilirubin total and direct measurement | INR

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0085584
UMLS CUI [5,1]
C0232741
UMLS CUI [5,2]
C0332271
UMLS CUI [6]
C0201838
UMLS CUI [7]
C0391937
UMLS CUI [8]
C0525032
co-infection with hiv or hepatitis b (defined as hbsag-positive) at screening
Description

HIV coinfection | HBV coinfection | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
UMLS CUI [3]
C0149709
use of mtor inhibitors (everolimus or sirolimus) in the 6 months prior to screening
Description

mTOR Inhibitor | Everolimus | Sirolimus

Data type

boolean

Alias
UMLS CUI [1]
C2746052
UMLS CUI [2]
C0541315
UMLS CUI [3]
C0072980
antiviral treatment for hcv administered at any time after liver transplantation
Description

Antiviral Therapy HCV | Status post Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0220847
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0023911
patients on daily doses of corticosteroids higher than 5 mg/day
Description

Adrenal Cortex Hormones Daily Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C2348070
patients with fibrosing cholestatic hepatitis
Description

Cholestatic hepatitis Fibrosing

Data type

boolean

Alias
UMLS CUI [1,1]
C0149904
UMLS CUI [1,2]
C0543638
patients with current diagnosis of malignancies, including lymphoproliferative disorders
Description

Malignant Neoplasms | Lymphoproliferative Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0024314
patients with platelet count <70,000/mm3 or neutrophiles <1,500/mm3
Description

Platelet Count measurement | Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0200633
history of hcc outside milan criteria based on radiology or ucsf criteria based on analysis of the explant
Description

Liver carcinoma Radiology | Liver carcinoma Explant technique

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0043299
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0444933
Back to the top of the page

Similar models

Eligibility Hepatitis C NCT00938860

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Transplantation of liver | Etiology Cirrhosis due to hepatitis C | Liver carcinoma Pre Transplant | Absence Liver carcinoma Pre Transplant
Item
liver transplantation performed at least 6 months and up to 5 years prior randomization and due to hcv cirrhosis, with or without pre-transplant hepatocellular carcinoma (hcc) within milan or ucsf criteria
boolean
C0023911 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C2075271 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0040732 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
C0040732 (UMLS CUI [4,4])
Therapeutic immunosuppression | Tacrolimus
Item
immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization
boolean
C0021079 (UMLS CUI [1])
C0085149 (UMLS CUI [2])
Hepatitis C HCV genotype determination
Item
diagnosis of hcv genotypes 1 or 4 infection prior to transplantationconfirmed at screening
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Indication PEGINTERFERON/RIBAVIRIN | Hepatitis C, Chronic | Fibrosis stage Ishak Score Biopsy of liver | Fibrosis stage Knodell Fibrosis Score Biopsy of liver
Item
indication of treatment with peg-ifn and ribavirin due to histological evidence of chronic hcv infection defined as a fibrosis stage equal or greater than 1 using the ishak-knodell scoring system (ik ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization.
boolean
C3146298 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
C0524910 (UMLS CUI [2])
C1954435 (UMLS CUI [3,1])
C2986945 (UMLS CUI [3,2])
C0193388 (UMLS CUI [3,3])
C1954435 (UMLS CUI [4,1])
C3898641 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Creatinine measurement, serum | Estimated Glomerular Filtration Rate | Modification of diet in renal disease formula | Cockcroft-Gault formula
Item
serum creatinine >150 μmol/l (1.6 7 mg/dl) or egfr < 50 ml/min (4-variable modification of diet in renal disease [mdrd cockcroft-gault formula])
boolean
C0201976 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C3839656 (UMLS CUI [3])
C2924627 (UMLS CUI [4])
Recipient Organ Transplant multiple
Item
multi-organ transplant recipients
boolean
C1709854 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
Steroids Acute Rejection Episode | Steroids Acute Rejection Episode Quantity | Steroids Resistance | Acute Rejection Episode Quantity | Chronic graft rejection | Ductopenia
Item
recent episode of steroid-treated acute rejection (ar) within 3 months prior to randomization, or >1 episode of steroid-treated ar in the last 6 months, or any number of steroid-resistant ar episodes in the last 6 months including evidence of chronic rejection or ductopenia
boolean
C0038317 (UMLS CUI [1,1])
C3273245 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2,1])
C3273245 (UMLS CUI [2,2])
C0332189 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0038317 (UMLS CUI [3,1])
C0013203 (UMLS CUI [3,2])
C3273245 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0301948 (UMLS CUI [5])
C3830376 (UMLS CUI [6])
Condition Causing Graft dysfunction | Exception Hepatitis C
Item
evidence of conditions that could cause graft dysfunction other than hcv infection
boolean
C0348080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1167870 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Signs Decompensated liver disease | Ascites | Bleeding varices | Encephalopathy | Liver function deteriorating | Albumin measurement | Bilirubin total and direct measurement | INR
Item
patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin <3.5g/dl or, total direct bilirubin >1.5mg/dl or, inr >1.5)
boolean
C0311392 (UMLS CUI [1,1])
C4075847 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
C0232741 (UMLS CUI [5,1])
C0332271 (UMLS CUI [5,2])
C0201838 (UMLS CUI [6])
C0391937 (UMLS CUI [7])
C0525032 (UMLS CUI [8])
HIV coinfection | HBV coinfection | Hepatitis B surface antigen positive
Item
co-infection with hiv or hepatitis b (defined as hbsag-positive) at screening
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
mTOR Inhibitor | Everolimus | Sirolimus
Item
use of mtor inhibitors (everolimus or sirolimus) in the 6 months prior to screening
boolean
C2746052 (UMLS CUI [1])
C0541315 (UMLS CUI [2])
C0072980 (UMLS CUI [3])
Antiviral Therapy HCV | Status post Transplantation of liver
Item
antiviral treatment for hcv administered at any time after liver transplantation
boolean
C0280274 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0023911 (UMLS CUI [2,2])
Adrenal Cortex Hormones Daily Dose
Item
patients on daily doses of corticosteroids higher than 5 mg/day
boolean
C0001617 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Cholestatic hepatitis Fibrosing
Item
patients with fibrosing cholestatic hepatitis
boolean
C0149904 (UMLS CUI [1,1])
C0543638 (UMLS CUI [1,2])
Malignant Neoplasms | Lymphoproliferative Disorders
Item
patients with current diagnosis of malignancies, including lymphoproliferative disorders
boolean
C0006826 (UMLS CUI [1])
C0024314 (UMLS CUI [2])
Platelet Count measurement | Neutrophil count
Item
patients with platelet count <70,000/mm3 or neutrophiles <1,500/mm3
boolean
C0032181 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
Liver carcinoma Radiology | Liver carcinoma Explant technique
Item
history of hcc outside milan criteria based on radiology or ucsf criteria based on analysis of the explant
boolean
C2239176 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0444933 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial