NCT03707080

Direct Acting Antiviral-Post Authorization Safety Study

DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Target PharmaSolutions, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.

Conditions

• Hepatitis C
• Hepatocellular Carcinoma

Timeline

• Start date: 2018-03-09
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-10-16
• Last updated: 2021-07-06

Locations

62 sites across 5 countries: United States, France, Germany, Italy, Spain