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NCT02278419 - A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 He

A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infection


Data Specification

Not Available


Annotated CRF

Not Available

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Product Info

Generic Name
Simeprevir
Product Name
OLYSIO®
Therapeutic Area
Viral Diseases
Enrollment
63
% Female
46.0%
% White
N/A
Product Class
Antiviral Agent
Sponsor Protocol Number
CR104970  TMC435HPC2014
Data Holder
Johnson & Johnson
Condition Studied
Hepatitis C
Mean/Median Age (Years)
51.0

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 
2

Disclaimer

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