Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study
Conditions: Chronic Hepatitis C, Genotype 1
Sponsor: AbbVie

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vir and dasab
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06.2015
rld Evidenc
asvir, ± Dasa
Hepatitis C 
tional, Multi
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the effective
vity and hea
n-free regim
vir, ± Ribavir
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NCT02669940

 
 
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Table 
Table of 
Abbrevia
Responsi
Abstract
Amendm
Mileston
Rational
Backgroun
Rationale .
Research
Research Q
Objectives
Primary Ob
Secondary
Research
Study Desi
Setting .....
Target Pop
Study Dura
Terminatio
Investigato
Variables .
Primary V
Secondary
Data Sourc
Data to be 
Inclusion D
During Tre
Post-Treatm
HCV RNA
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of Conte
Contents
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t ..............
ments and
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Question ....
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bjective .....
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h Method
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on Criteria ..
or Selection 
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nex 1.
Paritaprevir/
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Standardiz
Study Size
Data Mana
Electronic 
Assignmen
Data Analy
Analysis P
Data .........
Demograp
Effectivene
Primary Ef
Secondary
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Abbrevi
 
AE 
APRI 
AFP 
ALT 
AST 
ABBVIE 
REGIME
ANCOVA
BMI 
CA 
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CI 
CNI 
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γ-GT 
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3. To
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4. To
5. To
prod
6. To
utiliz
9.0
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06.2015
ities and co
BBVIE REG
VIE REGIME
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9.1 a
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06.2015
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Study
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06.2015
udy. The inc
of the study 
receiving 12
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Versio
9.3
9.3
9.3
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9.4
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06.2015
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edication 
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9.4.
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nterleukin 2
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mentation
 genotypes
mode of infe
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9.4.1.5 
Remarks 
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Versio
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ent related h
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vir and dasab
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06.2015
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resource uti
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06.2015
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Lower limit o
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06.2015
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06.2015
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06.2015
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