ID

42016

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

Mots-clés

Versions (2)
  1. 21/03/2016 21/03/2016 -
  2. 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

15 mars 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Concomitant Therapy

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VX-950HPC3006 NCT01571583 Concomitant Therapy

1 Formulaires  
Concomitant Therapy
Description

Concomitant Therapy

Alias
UMLS CUI-1
C1707479
Therapy
Description

Therapy

Type de données

text

Alias
UMLS CUI [1]
C0087111
Indication or AE
Description

If AE associated with this CM, please complete the AE page and create an association with the corresponding AE

Type de données

integer

Alias
UMLS CUI [1]
C3146298
UMLS CUI [2]
C0877248
Prophylaxis
Description

Prophylaxis

Type de données

boolean

Alias
UMLS CUI [1]
C0199176
Dose per intake
Description

Dose per intake

Type de données

text

Alias
UMLS CUI [1]
C3174092
unit
Description

Unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
frequency
Description

frequency

Type de données

integer

Alias
UMLS CUI [1]
C3476109
route of administration
Description

route of administration

Type de données

integer

Alias
UMLS CUI [1]
C0013153
start of therapy
Description

start of therapy

Type de données

integer

Alias
UMLS CUI [1]
C3173309
end of therapy
Description

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

Type de données

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
row number
Description

(for office use only)

Type de données

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 NCT01571583 Concomitant Therapy

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Concomitant Therapy
C1707479 (UMLS CUI-1)
Therapy
Item
Therapy
text
C0087111 (UMLS CUI [1])
Item
Indication or AE
integer
C3146298 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
Indication or AE
Code List
Indication or AE
CL Item
indication please specify: (1)
CL Item
AE (2)
Prophylaxis
Item
Prophylaxis
boolean
C0199176 (UMLS CUI [1])
Dose per intake
Item
Dose per intake
text
C3174092 (UMLS CUI [1])
Unit
Item
unit
text
C1519795 (UMLS CUI [1])
Item
frequency
integer
C3476109 (UMLS CUI [1])
frequency
Code List
frequency
CL Item
q.d. - once daily (1)
CL Item
b.i.d. - twice daily (2)
CL Item
t.i.d. - three times daily (3)
CL Item
q.i.d. - four times daily (4)
CL Item
other, specify (5)
Item
route of administration
integer
C0013153 (UMLS CUI [1])
route of administration
Code List
route of administration
CL Item
oral (1)
CL Item
other, specify (2)
Item
start of therapy
integer
C3173309 (UMLS CUI [1])
start of therapy
Code List
start of therapy
CL Item
pre-trial (1)
CL Item
start date, please specify: (2)
Item
end of therapy
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
end of therapy
Code List
end of therapy
CL Item
end date, please specify (1)
CL Item
ongoing at end of the trial (2)
row number
Item
row number
text
C0237753 (UMLS CUI [1])
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