ID

44763

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 (4)
  1. 23/03/2016 23/03/2016 -
  2. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
  3. 20/09/2021 20/09/2021 -
  4. 17/11/2021 17/11/2021 -
Détendeur de droits

Janssen-Cilag International NV

Téléchargé le

17 novembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
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VX-950HPC3006 NCT01571583 Follow-Up Assignment

Anglais

VX-950HPC3006 NCT01571583 Follow-Up Assignment

1 Formulaires  
Follow-Up Assignment
Description

Follow-Up Assignment

Did the subject receive at least 4 weeks of Telaprevir treatment?
Description

Telaprevir treatment duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C1876229
UMLS CUI [1,2]
C0449238
Did the subject complete the full 48 weeks of treatment?
Description

full duration of treament

Type de données

boolean

Alias
UMLS CUI [1,1]
C0444921
UMLS CUI [1,2]
C0205197
HCV RNA Status at End of treatment
Description

HCV RNA Status

Type de données

integer

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0444930
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Similar models

VX-950HPC3006 NCT01571583 Follow-Up Assignment

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Follow-Up Assignment
Telaprevir treatment duration
Item
Did the subject receive at least 4 weeks of Telaprevir treatment?
boolean
C1876229 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
full duration of treament
Item
Did the subject complete the full 48 weeks of treatment?
boolean
C0444921 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
HCV RNA Status at End of treatment
integer
C0369335 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
HCV RNA Status
Code List
HCV RNA Status at End of treatment
CL Item
Detectable HCV RNA (1)
CL Item
Undetectable HCV RNA (2)
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