ID

39743

Beschreibung

A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT01938625

Link

https://clinicaltrials.gov/show/NCT01938625

Stichworte

Versionen (1)
  1. 14.02.20 14.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01938625

Englisch

Eligibility Hepatitis C, Chronic NCT01938625

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
liver transplant between 6 months and 10 years prior to the screening visit
Beschreibung

Transplantation of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0023911
hepatitis c virus (hcv) genotype 1 subtype b infection confirmed at screening
Beschreibung

Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
screening hcv ribose nucleic acid level greater than 10,000 iu/ml
Beschreibung

Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1272251
hcv treatment-naïve participants must not have received post orthotopic liver transplant treatment with any approved or investigational drug for the treatment of hcv
Beschreibung

Therapy naive Hepatitis C | Therapeutic procedure Absent Post Orthotopic liver transplant | Pharmacotherapy Absent Hepatitis C | Investigational New Drugs Absent Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C0400447
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0019196
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0019196
receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine (only allowed in part 1) or tacrolimus for more than 3 months prior to the screening visit
Beschreibung

Immunosuppressant drug therapy Stable | Dose unchanged | Cyclosporine | Tacrolimus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096650
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0442739
UMLS CUI [3]
C0010592
UMLS CUI [4]
C0085149
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
Beschreibung

Hepatic decompensation | Hepatic decompensation chronic | Status post Transplantation of liver | Ascites | Bleeding varices | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2,1]
C1394798
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0023911
UMLS CUI [4]
C0003962
UMLS CUI [5]
C0333106
UMLS CUI [6]
C0019151
any liver disease of non-hcv etiology, including current evidence of graft rejection except the presence of liver steatosis
Beschreibung

Liver disease | Etiology Except HCV | Graft Rejection | Exception Hepatic steatosis Present

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C0018129
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015695
UMLS CUI [4,3]
C0150312
any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavirin
Beschreibung

Disease Clinical Significance | Exacerbation Due to Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0035525
coinfection with hcv of another genotype than genotype 1b, hiv type 1 or 2 (positive hiv-1 or hiv-2 antibodies test at screening), and hepatitis b virus (hepatitis b surface antigen positive)
Beschreibung

HCV coinfection Genotype | Coinfection HIV-1 | Coinfection HIV-2 | Human immunodeficiency virus type 1 antibody Positive | HIV-2 Antibody Positive | HBV coinfection | Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019704
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0019707
UMLS CUI [4,1]
C0369497
UMLS CUI [4,2]
C1514241
UMLS CUI [5,1]
C0373917
UMLS CUI [5,2]
C1514241
UMLS CUI [6]
C2242656
UMLS CUI [7]
C0149709
multi-organ transplant that included heart, lung, pancreas, or kidney
Beschreibung

Organ Transplantation multiple | Heart | Lung | Pancreas | Kidney

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0439064
UMLS CUI [2]
C0018787
UMLS CUI [3]
C0024109
UMLS CUI [4]
C0030274
UMLS CUI [5]
C0022646
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Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT01938625

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Transplantation of liver
Item
liver transplant between 6 months and 10 years prior to the screening visit
boolean
C0023911 (UMLS CUI [1])
Hepatitis C Genotype
Item
hepatitis c virus (hcv) genotype 1 subtype b infection confirmed at screening
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
screening hcv ribose nucleic acid level greater than 10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Therapy naive Hepatitis C | Therapeutic procedure Absent Post Orthotopic liver transplant | Pharmacotherapy Absent Hepatitis C | Investigational New Drugs Absent Hepatitis C
Item
hcv treatment-naïve participants must not have received post orthotopic liver transplant treatment with any approved or investigational drug for the treatment of hcv
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0400447 (UMLS CUI [2,4])
C0013216 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0019196 (UMLS CUI [4,3])
Immunosuppressant drug therapy Stable | Dose unchanged | Cyclosporine | Tacrolimus
Item
receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine (only allowed in part 1) or tacrolimus for more than 3 months prior to the screening visit
boolean
C1096650 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0010592 (UMLS CUI [3])
C0085149 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Hepatic decompensation | Hepatic decompensation chronic | Status post Transplantation of liver | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
boolean
C1394798 (UMLS CUI [1])
C1394798 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
C0003962 (UMLS CUI [4])
C0333106 (UMLS CUI [5])
C0019151 (UMLS CUI [6])
Liver disease | Etiology Except HCV | Graft Rejection | Exception Hepatic steatosis Present
Item
any liver disease of non-hcv etiology, including current evidence of graft rejection except the presence of liver steatosis
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0018129 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0015695 (UMLS CUI [4,2])
C0150312 (UMLS CUI [4,3])
Disease Clinical Significance | Exacerbation Due to Ribavirin
Item
any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavirin
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C4086268 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
HCV coinfection Genotype | Coinfection HIV-1 | Coinfection HIV-2 | Human immunodeficiency virus type 1 antibody Positive | HIV-2 Antibody Positive | HBV coinfection | Hepatitis B surface antigen positive
Item
coinfection with hcv of another genotype than genotype 1b, hiv type 1 or 2 (positive hiv-1 or hiv-2 antibodies test at screening), and hepatitis b virus (hepatitis b surface antigen positive)
boolean
C1698259 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0019704 (UMLS CUI [2,2])
C0275524 (UMLS CUI [3,1])
C0019707 (UMLS CUI [3,2])
C0369497 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0373917 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C2242656 (UMLS CUI [6])
C0149709 (UMLS CUI [7])
Organ Transplantation multiple | Heart | Lung | Pancreas | Kidney
Item
multi-organ transplant that included heart, lung, pancreas, or kidney
boolean
C0029216 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0018787 (UMLS CUI [2])
C0024109 (UMLS CUI [3])
C0030274 (UMLS CUI [4])
C0022646 (UMLS CUI [5])
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