Direct Acting Antiviral-Post Authorization Safety Study

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707080
• Other study ID #: TARGET-HCC DAA-PASS
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2021
• Source: Target PharmaSolutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis C
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
France	CHU de Nice - Hôpital L'Archet 2	Nice
France	Hôpitaux Universitaires Paris Centre	Paris
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinikum Magdeburg	Magdeburg
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Italy	A.O.U.P. di Palermo	Palermo
Italy	Humanitas Mirasole IRCCS	Rozzano
Italy	IRCCS "Casa Sollievo della Sofferenza"	San Giovanni Rotondo
Spain	Hospital Puerta de Hierro Majadahonda	Madrid
Spain	Clínica Universidad de Navarra	Pamplona
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Politècnic La Fe	Valencia
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Atlanta Hospital	Atlanta	Georgia
United States	Mercy Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas HealthCare System Center for Liver Disease	Charlotte	North Carolina
United States	University of Virginia Transplant Center	Charlottesville	Virginia
United States	Northwestern University Division of Gastroenterology and Hepatology	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Gastro Florida	Clearwater	Florida
United States	Clinical Research Institute@ Methodist Dallas Medical Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Baylor Scott & White All Saints	Fort Worth	Texas
United States	University of Florida Hepatology Research at CTRB	Gainesville	Florida
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Research Specialists of Texas	Houston	Texas
United States	Research Specialists of Texas	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Southern Therapy and Advanced Research LLC	Jackson	Mississippi
United States	University of Florida - Health Gastroenerology	Jacksonville	Florida
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Norris Comprehensive Cancer Center	Los Angeles	California
United States	Northwell Health - Center for Liver Disease	Manhasset	New York
United States	Schiff Center for Liver Diseases	Miami	Florida
United States	Vanderbilt University Medical Center - GI Research Office	Nashville	Tennessee
United States	Rutgers-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	New York University Langone Health	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Stanford University	Palo Alto	California
United States	California Liver Research Institute	Pasadena	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center	Phoenix	Arizona
United States	Providence Health & Services Cancer Clinical Trials	Portland	Oregon
United States	Bon Secours Liver Institute of Virginia	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California - Davis Clinical Trials	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	University of California - San Francisco	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Tampa General Medical Group	Tampa	Florida
United States	Georgetown University	Washington	District of Columbia
United States	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to HCC recurrence - Prospective Cohort	Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.	up to 24 months
Secondary	Number of events of early HCC recurrence - Prospective Cohort	Number of events (early HCC recurrence) associated with DAA therapy relative to no DAA therapy in the prospective cohort.	up to 24 months
Secondary	Time to HCC recurrence - Prospective Cohort relative to Historical Cohort	Time to HCC recurrence associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort.	up to 24 months
Secondary	Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort	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.	up to 24 months