ID

14005

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

Geüploaded op

22 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 PK Sampling TAC/CsA

Engels

VX-950HPC3006 NCT01571583 PK Sampling TAC/CsA

1 Formulieren  
PK Sampling TAC/CsA
Beschrijving

PK Sampling TAC/CsA

Type of most recent immunosuppressant intake prior to this visit
Beschrijving

Type of most recent immunosuppressant intake prior to this visit

Datatype

integer

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C0332152
actual date and time of most recent intake of immunosuppressant prior to this visit
Beschrijving

actual date and time of most recent intake of immunosuppressant prior to this visit

Datatype

datetime

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C0332152
UMLS CUI [3]
C0011008
actual date and time of sampling
Beschrijving

sampling date and time

Datatype

integer

Alias
UMLS CUI [1,1]
C0870078
UMLS CUI [1,2]
C0011008
remarks if any
Beschrijving

remarks

Datatype

text

Alias
UMLS CUI [1]
C0947611
immunosuppressant concentration
Beschrijving

immunosuppressant concentration

Datatype

text

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1446561
immunosuppressant concentration unit
Beschrijving

immunosuppressant concentration unit

Datatype

integer

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1446561
UMLS CUI [1,3]
C1519795
local laboratory name
Beschrijving

local laboratory name

Datatype

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C1301943
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Similar models

VX-950HPC3006 NCT01571583 PK Sampling TAC/CsA

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
PK Sampling TAC/CsA
Item
Type of most recent immunosuppressant intake prior to this visit
integer
C0021081 (UMLS CUI [1])
C0545082 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Type of most recent immunosuppressant intake prior to this visit
Code List
Type of most recent immunosuppressant intake prior to this visit
CL Item
Tacrolimus (1)
CL Item
Cyclosporin A (2)
actual date and time of most recent intake of immunosuppressant prior to this visit
Item
actual date and time of most recent intake of immunosuppressant prior to this visit
datetime
C0021081 (UMLS CUI [1])
C0545082 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
actual date and time of sampling
integer
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
sampling date and time
Code List
actual date and time of sampling
CL Item
not done (1)
CL Item
same date as visit date (2)
CL Item
other date please specify: (3)
remarks
Item
remarks if any
text
C0947611 (UMLS CUI [1])
immunosuppressant concentration
Item
immunosuppressant concentration
text
C0021081 (UMLS CUI [1,1])
C1446561 (UMLS CUI [1,2])
Item
immunosuppressant concentration unit
integer
C0021081 (UMLS CUI [1,1])
C1446561 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
immunosuppressant concentration unit
Code List
immunosuppressant concentration unit
CL Item
mcg/ml (1)
CL Item
ng/ml (2)
CL Item
pg/ml (3)
local laboratory name
Item
local laboratory name
text
C0022877 (UMLS CUI [1,1])
C1301943 (UMLS CUI [1,2])
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