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NCT00882908 - A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naiv

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects


Data Specification

Not Available


Annotated CRF

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Product Info

Generic Name
Simeprevir
Product Name
OLYSIO®
Therapeutic Area
Viral Diseases
Enrollment
386
% Female
44.8%
% White
93.8%
Product Class
Antiviral Agent
Sponsor Protocol Number
TMC435-C205
Data Holder
Johnson & Johnson
Condition Studied
Hepatitis C
Mean/Median Age (Years)
46.5

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
2

Disclaimer

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