NCT02537379

Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

A Prospective Observational Post-Marketing Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 552 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF	SOF 400 mg tablets administered orally once daily
DRUG	COPE	COPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)

Timeline

• Start date: 2015-09-15
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2015-09-01
• Last updated: 2017-06-27

Locations

45 sites across 1 country: Japan