ID

13988

Description

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

Keywords

Versions (1)
  1. 3/21/16 3/21/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 21, 2016

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Adverse Event

English

VX-950HPC3006 NCT01571583 Adverse Event

1 forms  
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Adverse event number
Description

Adverse event number

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Adverse event
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
adverse event type
Description

adverse event type

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0332307
start of event
Description

start of event

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
end of event
Description

please only complete "ongoing" at the end of the trial

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
outcome
Description

outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
concomitant therapy started because of AE
Description

if concomitant therapy is given please complete the CM Page and create an association with the corresponding CM

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0877248
relation to investigational medication Telaprevir
Description

relation to investigational medication Telaprevir

Data type

integer

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C1876229
relation to investigational medication Ribavirin
Description

relation to investigational medication Ribavirin

Data type

integer

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0035525
relation to investigational medication Peg-IFN
Description

relation to investigational medication Peg-IFN

Data type

integer

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0907160
related to HCV-infection
Description

related to HCV-infection

Data type

boolean

Alias
UMLS CUI [1,1]
C1706735
UMLS CUI [1,2]
C0019196
severity according to DAIDS grading scale, or severity according to protocol for rash events
Description

severity

Data type

integer

Alias
UMLS CUI [1]
C1710066
action taken regarding investigational medication Telaprevir
Description

medication change Telaprevir

Data type

integer

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C1876229
actions taken regarding investigational medication Ribavirin
Description

medication change Ribavirin

Data type

integer

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0035525
action taken regarding investigational medication Peg-IFN
Description

medication change Peg-IFN

Data type

integer

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0907160
Is this a serious AE?
Description

If Yes, please complete the section below, specifying the reason(s) the AE is serious

Data type

boolean

Alias
UMLS CUI [1]
C1519255
adverse event resulting in death
Description

adverse event resulting in death

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3151529
life threatening adverse event
Description

life threatening adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1517874
hospitalization / prolonged hospitalization
Description

hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0877248
persistent/significant disability/incapacity
Description

persistent/significant disability/incapacity

Data type

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C0877248
congenital anomaly/birth defect
Description

congenital anomaly/birth defect

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0877248
other medically important serious event
Description

other medically important serious event

Data type

boolean

Alias
UMLS CUI [1,1]
C2826307
UMLS CUI [1,2]
C0205394
GMS number
Description

GMS number

Data type

text

Alias
UMLS CUI [1]
C0237753
Office use only
Description

Office use only

Data type

text

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Similar models

VX-950HPC3006 NCT01571583 Adverse Event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Adverse event number
Item
Adverse event number
text
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Item
adverse event type
integer
C0877248 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
adverse event type
Code List
adverse event type
CL Item
rash, please complete rash visits (1)
CL Item
liver graft rejection, please complete Graft Rejection form (2)
CL Item
other (3)
start of event
Item
start of event
date
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
end of event
integer
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
end of event
Code List
end of event
CL Item
end date please specify (1)
CL Item
ongoing at the end of the trial (2)
Item
outcome
integer
C1705586 (UMLS CUI [1])
outcome
Code List
outcome
CL Item
recovered/resolved (1)
CL Item
not recovered/not resolved (2)
CL Item
recovered/resolved with sequelae (3)
CL Item
fatal, please complete date of death (4)
CL Item
unknown (5)
concomitant therapy started because of AE
Item
concomitant therapy started because of AE
boolean
C1707479 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
relation to investigational medication Telaprevir
integer
C1510821 (UMLS CUI [1,1])
C1876229 (UMLS CUI [1,2])
relation to investigational medication Telaprevir
Code List
relation to investigational medication Telaprevir
CL Item
not related (1)
CL Item
unlikely related (2)
CL Item
possibly related (3)
CL Item
related (4)
Item
relation to investigational medication Ribavirin
integer
C1510821 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
relation to investigational medication Ribavirin
Code List
relation to investigational medication Ribavirin
CL Item
not related (1)
CL Item
unlikely related (2)
CL Item
possibly related (3)
CL Item
related (4)
Item
relation to investigational medication Peg-IFN
integer
C1510821 (UMLS CUI [1,1])
C0907160 (UMLS CUI [1,2])
relation to investigational medication Peg-IFN
Code List
relation to investigational medication Peg-IFN
CL Item
not related (1)
CL Item
unlikely related (2)
CL Item
possibly related (3)
CL Item
related (4)
related to HCV-infection
Item
related to HCV-infection
boolean
C1706735 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Item
severity according to DAIDS grading scale, or severity according to protocol for rash events
integer
C1710066 (UMLS CUI [1])
undefined item
Code List
severity according to DAIDS grading scale, or severity according to protocol for rash events
CL Item
Grade 1 or mild (1)
CL Item
Grade 2 or moderate (2)
CL Item
Grade 3 or severe (3)
CL Item
Grade 4 or potentially life threatening (4)
Item
action taken regarding investigational medication Telaprevir
integer
C0580105 (UMLS CUI [1,1])
C1876229 (UMLS CUI [1,2])
medication change
Code List
action taken regarding investigational medication Telaprevir
CL Item
Dose not changed (1)
CL Item
Not applicable (2)
CL Item
Drug withdrawn (3)
CL Item
Drug interrupted (4)
CL Item
Dose reduced (5)
CL Item
Dose increased (6)
CL Item
Unknown (7)
Item
actions taken regarding investigational medication Ribavirin
integer
C0580105 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
medication change Ribavirin
Code List
actions taken regarding investigational medication Ribavirin
CL Item
Dose not changed (1)
CL Item
Not applicable (2)
CL Item
Drug withdrawn (3)
CL Item
Drug interrupted (4)
CL Item
Dose reduced (5)
CL Item
Dose increased (6)
CL Item
Unknown (7)
Item
action taken regarding investigational medication Peg-IFN
integer
C0580105 (UMLS CUI [1,1])
C0907160 (UMLS CUI [1,2])
medication change Peg-IFN
Code List
action taken regarding investigational medication Peg-IFN
CL Item
Dose not changed (1)
CL Item
Not applicable (2)
CL Item
Drug withdrawn (3)
CL Item
Drug interrupted (4)
CL Item
Dose reduced (5)
CL Item
Dose increased (6)
CL Item
Unknown (7)
serious adverse event
Item
Is this a serious AE?
boolean
C1519255 (UMLS CUI [1])
adverse event resulting in death
Item
adverse event resulting in death
boolean
C0877248 (UMLS CUI [1,1])
C3151529 (UMLS CUI [1,2])
life threatening adverse event
Item
life threatening adverse event
boolean
C1517874 (UMLS CUI [1])
hospitalization
Item
hospitalization / prolonged hospitalization
boolean
C0019993 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
persistent/significant disability/incapacity
Item
persistent/significant disability/incapacity
boolean
C0231170 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
congenital anomaly/birth defect
Item
congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
other medically important serious event
Item
other medically important serious event
boolean
C2826307 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
GMS number
Item
GMS number
text
C0237753 (UMLS CUI [1])
Office use only
Item
Office use only
text
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