Trial Search Results

Direct Acting Antiviral-Post Authorization Safety Study

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Target PharmaSolutions, Inc.

Stanford Investigator(s):

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pranali Suryavanshi
650-721-4288
Recruiting