Direct Acting Antiviral-Post Authorization Safety Study

DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03707080

Enrollment

Registered

2018-10-16

Start date

2018-03-09

Completion date

2021-06-30

Last updated

2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Hepatocellular Carcinoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Time to HCC recurrence - Prospective Cohort	up to 24 months	Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.

Secondary

Measure	Time frame	Description
Number of events of early HCC recurrence - Prospective Cohort	up to 24 months	Number of events (early HCC recurrence) associated with DAA therapy relative to no DAA therapy in the prospective cohort.
Time to HCC recurrence - Prospective Cohort relative to Historical Cohort	up to 24 months	Time to HCC recurrence associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort.
Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort	up to 24 months	Number of events (early HCC recurrence) associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort. historical cohort of HCV patients not exposed to DAA with initial HCC diagnosis and subsequent successful treatment of HCC.

Countries

France, Germany, Italy, Spain, United States

Outcome results