Direct Acting Antiviral-Post Authorization Safety Study
Trial ID or NCT#
Status
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
- * 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
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Swati Toppo
650-497-4151
View on ClinicalTrials.gov