Direct Acting Antiviral-Post Authorization Safety Study

Not Recruiting

Trial ID: NCT03707080

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

Stanford Investigator(s)

Paul Kwo
Paul Kwo

Professor of Medicine (Gastroenterology and Hepatology)

Eligibility

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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Swati Toppo
650-497-4151