NCT02253550

Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Without Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peter J. Ruane, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.

Detailed description

Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Simeprevir	Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.
DRUG	Sofosbuvir	Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-10-01
• Last updated: 2016-02-24

Locations

1 site across 1 country: United States