Direct Acting Antiviral-Post Authorization Safety Study

Trial ID or NCT#

NCT03707080

Status

recruiting iconRECRUITING

Purpose

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
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Investigator(s)

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

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Contact

Swati Toppo
650-497-4151

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View on ClinicalTrials.gov