ID

29715

Descrição

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

Palavras-chave

Versões (1)
  1. 15/04/2018 15/04/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de abril de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00938860

Inglês

Eligibility Hepatitis C NCT00938860

1 Formulários  
Inclusion Criteria
Descrição

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
Descrição

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

Tipo de dados

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
Descrição

Therapeutic immunosuppression | Tacrolimus

Tipo de dados

boolean

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

Hepatitis C HCV genotype determination

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

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])
Descrição

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

Tipo de dados

boolean

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

Recipient Organ Transplant multiple

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Condition Causing Graft dysfunction | Exception Hepatitis C

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

HIV coinfection | HBV coinfection | Hepatitis B surface antigen positive

Tipo de dados

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
Descrição

mTOR Inhibitor | Everolimus | Sirolimus

Tipo de dados

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
Descrição

Antiviral Therapy HCV | Status post Transplantation of liver

Tipo de dados

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
Descrição

Adrenal Cortex Hormones Daily Dose

Tipo de dados

boolean

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

Cholestatic hepatitis Fibrosing

Tipo de dados

boolean

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

Malignant Neoplasms | Lymphoproliferative Disorders

Tipo de dados

boolean

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

Platelet Count measurement | Neutrophil count

Tipo de dados

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
Descrição

Liver carcinoma Radiology | Liver carcinoma Explant technique

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0043299
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0444933
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Similar models

Eligibility Hepatitis C NCT00938860

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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