Summary

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

Description

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.

Official Title

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

Keywords

Hepatitis C Hepatocellular Carcinoma Carcinoma Carcinoma, Hepatocellular Prospective Historical

Eligibility

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

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Target PharmaSolutions, Inc.
ID
NCT03707080
Study Type
Observational
Last Updated