ID

14015

Descripción

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

Palabras clave

Versiones (1)
  1. 22/3/16 22/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

22 de marzo de 2016

DOI

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Licencia

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

Inglés

VX-950HPC3006 NCT01571583 Graft Rejection

1 formularios  
Assessments for liver graft rejection
Descripción

Assessments for liver graft rejection

Central laboratory, please provide central laboratory reference number
Descripción

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

Tipo de datos

text

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

Local laboratory date of collection

Tipo de datos

date

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

Ultrasound date

Tipo de datos

date

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

MRI date

Tipo de datos

date

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

Bile duct visualisation

Tipo de datos

integer

Bile duct visualisation date
Descripción

Bile duct visualisation date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Other please specify
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
BanFF Criteria Grade
Descripción

BanFF Criteria Grade

BanFF criteria grade
Descripción

BanFF criteria grade

Tipo de datos

integer

BanFF Criteria Grade Date
Descripción

BanFF Criteria Grade Date

Tipo de datos

date

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

Remarks

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
other criteria
Descripción

other criteria

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

if yes please specify

Tipo de datos

boolean

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

remarks

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
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Similar models

VX-950HPC3006 NCT01571583 Graft Rejection

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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