NCT02250001

Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,974 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.

Detailed description

Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)

Conditions

• Chronic Hepatitis C

Timeline

• Start date: 2014-09-30
• Primary completion: 2017-01-20
• Completion: 2017-01-20
• First posted: 2014-09-26
• Last updated: 2017-05-03

Locations

1 site across 1 country: Japan