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NCT01292239 - A Phase III, Randomized, Double-blind, Placebo-controlled Trial in Japan to Investigate the Efficacy and Safety of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naive, Genotype

A Phase III, Randomized, Double-blind, Placebo-controlled Trial in Japan to Investigate the Efficacy and Safety of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naive, Genotype 1, Hepatitis C-infected Subjects


CSR Summary

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Simeprevir
Product Name
OLYSIO®
Therapeutic Area
Viral Diseases
Enrollment
183
% Female
65.6%
% White
0.0%
Product Class
Antiviral Agent
Sponsor Protocol Number
TMC435HPC3003
Data Holder
Johnson & Johnson
Condition Studied
Hepatitis C
Mean/Median Age (Years)
55.0

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 
3

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