ID
14133
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)
- 3/31/16 3/31/16 -
Copyright Holder
CC BY-NC 3.0
Uploaded on
March 31, 2016
DOI
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License
Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Blood sample for local analysis
VX-950HPC3006 NCT01571583 Blood sample for local analysis
- StudyEvent: ODM
Description
Hemoglobin
Alias
- UMLS CUI-1
- C0019046
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
text based
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Hematocrit
Alias
- UMLS CUI-1
- C0518014
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
RBC Count
Alias
- UMLS CUI-1
- C0014772
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
MCH
Alias
- UMLS CUI-1
- C0369183
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
MCHC
Alias
- UMLS CUI-1
- C0474535
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
MCV
Alias
- UMLS CUI-1
- C1948043
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
RBC Morphology
Alias
- UMLS CUI-1
- C2599223
Description
Platelet Count
Alias
- UMLS CUI-1
- C0032181
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Reticulocyte Count
Alias
- UMLS CUI-1
- C0206161
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
WBC Count
Alias
- UMLS CUI-1
- C0023508
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Neutrophil Count
Alias
- UMLS CUI-1
- C0200633
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Neutrophil Percentage
Alias
- UMLS CUI-1
- C1171400
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Lymphocyte Count
Alias
- UMLS CUI-1
- C0200635
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Lymphocyte Percentage
Alias
- UMLS CUI-1
- C1171404
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Eosinophils Count
Alias
- UMLS CUI-1
- C0750879
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Eosinophils Percentage
Alias
- UMLS CUI-1
- C1171399
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Monocyte Count
Alias
- UMLS CUI-1
- C0200637
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Monocytes Percentage
Alias
- UMLS CUI-1
- C1171403
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Basophils Count
Alias
- UMLS CUI-1
- C0200641
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Basophils Percentage
Alias
- UMLS CUI-1
- C1171402
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
AST
Alias
- UMLS CUI-1
- C0201899
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
ALT
Alias
- UMLS CUI-1
- C0201836
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Creatinine
Alias
- UMLS CUI-1
- C0201976
Description
not done
Data type
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
clinically significant
Data type
boolean
Alias
- UMLS CUI [1]
- C2826633
Description
normal range lower limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
normal range upper limit
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Additional clinically significant results entry
Alias
- UMLS CUI-1
- C2826633
Description
Lab method
Data type
integer
Alias
- UMLS CUI [1]
- C0242485
- UMLS CUI [2]
- C1278039
- UMLS CUI [3]
- C1881193
- UMLS CUI [4]
- C0201916
- UMLS CUI [5]
- C0373670
- UMLS CUI [6]
- C0201883
- UMLS CUI [7]
- C0202035
Description
other lab method
Data type
text
Alias
- UMLS CUI [1]
- C0242485
Description
Value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
other unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
please ensure the unit is the same as the unit for the value
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827739
Description
please ensure the unit is the same as the unit for the value
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Description
normal range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
(for office use only)
Data type
text
Alias
- UMLS CUI [1]
- C0237753
Similar models
VX-950HPC3006 NCT01571583 Blood sample for local analysis
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C1301943 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C1881193 (UMLS CUI [3])
C0201916 (UMLS CUI [4])
C0373670 (UMLS CUI [5])
C0201883 (UMLS CUI [6])
C0202035 (UMLS CUI [7])
C2827739 (UMLS CUI [1,2])
C2827740 (UMLS CUI [1,2])