Direct Acting Antiviral-Post Authorization Safety Study

Trial ID or NCT#



recruiting iconRECRUITING


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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Current participant in TARGET-HCC - Adults, age ≥18 years - First diagnosis of HCC (mixed HCC/cholangiocarcinoma may be included). Diagnosis may be histological/cytological and/or radiological. - BCLC Stage A - Underwent, undergoing, or planned to undergo therapy for HCC, with exception that transplant as prior or planned treatment for HCC is excluded. - HCV RNA positive Screening
Exclusion Criteria:
  1. - Inability to provide informed consent - HCC-free imaging (as defined in Section 9.1.1) after treatment of initial HCC prior to Screening (see Section 9.2.9 for imaging details) - Prior liver transplantation - Hepatitis B Virus (HBV) surface antigen positive (HBsAg) - Previously treated with direct-acting antiviral agents (not DAA-naïve); Note that prior (peg)IFN and/or ribavirin therapy is allowed Enrollment Inclusion Criteria: - Continued participation in TARGET-HCC - No recurrence or progression of initial HCC beyond BCLC Stage A prior to Enrollment/Baseline - HCC-free imaging (as defined in Section 9.1.1) at Enrollment/Baseline (see Section 9.2.9 for imaging details; participants may remain in Screening until an HCC-free image is obtained) - Remains DAA-naïve (prior therapy with (peg)IFN and/or ribavirin is allowed) Enrollment Exclusion Criteria: - Liver transplantation since Screening


Paul Kwo
Paul Kwo
Hepatologist, Transplant hepatologist, Gastroenterologist
Professor of Medicine (Gastroenterology and Hepatology)

Contact us to find out if this trial is right for you.


Swati Toppo