ID

14015

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2016-03-22 2016-03-22 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

22 mars 2016

DOI

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Licens

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

Engelsk

VX-950HPC3006 NCT01571583 Graft Rejection

1 Formulär  
Assessments for liver graft rejection
Beskrivning

Assessments for liver graft rejection

Central laboratory, please provide central laboratory reference number
Beskrivning

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

Datatyp

text

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

Local laboratory date of collection

Datatyp

date

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

Ultrasound date

Datatyp

date

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

MRI date

Datatyp

date

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

Bile duct visualisation

Datatyp

integer

Bile duct visualisation date
Beskrivning

Bile duct visualisation date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Other please specify
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
BanFF Criteria Grade
Beskrivning

BanFF Criteria Grade

BanFF criteria grade
Beskrivning

BanFF criteria grade

Datatyp

integer

BanFF Criteria Grade Date
Beskrivning

BanFF Criteria Grade Date

Datatyp

date

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

Remarks

Datatyp

text

Alias
UMLS CUI [1]
C0947611
other criteria
Beskrivning

other criteria

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

if yes please specify

Datatyp

boolean

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

remarks

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Tillbaka till toppen

Similar models

VX-950HPC3006 NCT01571583 Graft Rejection

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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