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.
Target PharmaSolutions, Inc.
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
- 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