Clinical trial NCT03707080: Direct Acting Antiviral-Post Authorization Safety Study
Official title: DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Hepatocellular Carcinoma
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The prospective DAA-PASS cohort will include a subset of HCV RNA positive participants in the TARGET-HCC study who meet entry criteria including hepatitis C (with no prior history of DAA therapy) and newly diagnosed Barcelona Clinic Liver Cancer (BCLC) Stage A HCC. Participants will be enrolled in the countries participating in TARGET-HCC which will include: United States (US), France, Germany, Italy, and Spain.

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.


Eligibility 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 Exclusion Criteria:

- Liver transplantation since Screening

Primary outcomes:
measure: Time to HCC recurrence - Prospective Cohort
timeFrame: up to 24 months
Secondary outcomes:
measure: Number of events of early HCC recurrence - Prospective Cohort
timeFrame: up to 24 months
measure: Time to HCC recurrence - Prospective Cohort relative to Historical Cohort
timeFrame: up to 24 months
measure: Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: Norris Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Sacramento
country: United States
facility: University of California - Davis Clinical Trials
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research at CTRB
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Health Gastroenerology
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Division of Gastroenterology and Hepatology
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research LLC
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers-Robert Wood Johnson Medical School
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health - Center for Liver Disease
state: New York
city: New York
country: United States
facility: New York University Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas HealthCare System Center for Liver Disease
state: North Carolina
city: Portland
country: United States
facility: Providence Health & Services Cancer Clinical Trials
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - GI Research Office
state: Tennessee
city: Dallas
country: United States
facility: Clinical Research Institute@ Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Transplant Center
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Nice
country: France
facility: CHU de Nice - Hôpital L'Archet 2
city: Paris
country: France
facility: Hôpitaux Universitaires Paris Centre
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: A.O.U.P. di Palermo
city: Rozzano
country: Italy
facility: Humanitas Mirasole IRCCS
city: San Giovanni Rotondo
country: Italy
facility: IRCCS "Casa Sollievo della Sofferenza"
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario Politècnic La Fe
Study officials:
References: