for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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


Hepatitis C Hepatocellular Carcinoma Carcinoma Carcinoma, Hepatocellular Prospective Historical


For people ages 18 years and up

Screening Inclusion Criteria:

  • 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:

  • 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


  • University of California - San Francisco
    San Francisco California 94158 United States
  • Stanford University
    Palo Alto California 94304 United States


in progress, not accepting new patients
Start Date
Completion Date
Target PharmaSolutions, Inc.
Study Type
Last Updated