ID

42204

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 (4)
  1. 3/23/16 3/23/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
  4. 11/17/21 11/17/21 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 13, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

VX-950HPC3006 NCT01571583 Follow-Up Assignment

English

VX-950HPC3006 NCT01571583 Follow-Up Assignment

1 forms  
Follow-Up Assignment
Description

Follow-Up Assignment

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

Telaprevir treatment duration

Data type

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0444917
UMLS CUI [1,2]
C0205197
HCV RNA Status at End of treatment
Description

HCV RNA Status

Data type

integer

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
| C0087111
UMLS CUI [1,3]
C0444930
Back to the top of the page

Similar models

VX-950HPC3006 NCT01571583 Follow-Up Assignment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C0444917 (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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial