ID

14015

Beschrijving

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

Trefwoorden

Versies (1)
  1. 22-03-16 22-03-16 -
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CC BY-NC 3.0

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22 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Graft Rejection

Engels

VX-950HPC3006 NCT01571583 Graft Rejection

1 Formulieren  
Assessments for liver graft rejection
Beschrijving

Assessments for liver graft rejection

Central laboratory, please provide central laboratory reference number
Beschrijving

please complete the corresponding (scheduled or unscheduled visit) Lab form

Datatype

text

Alias
UMLS CUI [1,1]
C2826265
UMLS CUI [1,2]
C1880016
Local laboratory date of collection
Beschrijving

Local laboratory date of collection

Datatype

date

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0022877
Ultrasound date performed
Beschrijving

Ultrasound date

Datatype

date

Alias
UMLS CUI [1,1]
C1456803
UMLS CUI [1,2]
C0011008
MRI date
Beschrijving

MRI date

Datatype

date

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0011008
Bile duct visualisation
Beschrijving

Bile duct visualisation

Datatype

integer

Bile duct visualisation date
Beschrijving

Bile duct visualisation date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Other please specify
Beschrijving

Other

Datatype

text

Alias
UMLS CUI [1]
C0205394
BanFF Criteria Grade
Beschrijving

BanFF Criteria Grade

BanFF criteria grade
Beschrijving

BanFF criteria grade

Datatype

integer

BanFF Criteria Grade Date
Beschrijving

BanFF Criteria Grade Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Remarks, if any
Beschrijving

Remarks

Datatype

text

Alias
UMLS CUI [1]
C0947611
other criteria
Beschrijving

other criteria

other criteria upon which the diagnosis of liver graft rejection is made
Beschrijving

if yes please specify

Datatype

boolean

Alias
UMLS CUI [1]
C0205394
remarks, if any
Beschrijving

remarks

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

VX-950HPC3006 NCT01571583 Graft Rejection

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Assessments for liver graft rejection
Central laboratory
Item
Central laboratory, please provide central laboratory reference number
text
C2826265 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
Local laboratory date of collection
Item
Local laboratory date of collection
date
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2])
Ultrasound date
Item
Ultrasound date performed
date
C1456803 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
MRI date
Item
MRI date
date
C0024485 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Bile duct visualisation
integer
Bile duct visualisation
Code List
Bile duct visualisation
CL Item
ERCP (1)
CL Item
HIDA Scan (2)
CL Item
Other, please specify (3)
Bile duct visualisation date
Item
Bile duct visualisation date
date
C0011008 (UMLS CUI [1])
Other
Item
Other please specify
text
C0205394 (UMLS CUI [1])
Item Group
BanFF Criteria Grade
Item
BanFF criteria grade
integer
BanFF criteria grade
Code List
BanFF criteria grade
CL Item
Not Done (1)
CL Item
Date performed please specify (2)
BanFF Criteria Grade Date
Item
BanFF Criteria Grade Date
date
C0011008 (UMLS CUI [1])
Remarks
Item
Remarks, if any
text
C0947611 (UMLS CUI [1])
Item Group
other criteria
other criteria
Item
other criteria upon which the diagnosis of liver graft rejection is made
boolean
C0205394 (UMLS CUI [1])
remarks
Item
remarks, if any
text
C0947611 (UMLS CUI [1])
Terug naar het begin van de pagina 

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