Direct Acting Antiviral-Post Authorization Safety Study

NCT03707080 | Completed

• 1 other identifier: TARGET-HCC DAA-PASS
• Study Type: observational
• Target: 42
• Locations: 5 countries
• Sites: 62

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.

Conditions

Hepatitis C; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of events of early HCC recurrence - Prospective Cohort

  up to 24 months

• Time to HCC recurrence - Prospective Cohort relative to Historical Cohort

  up to 24 months

• Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort

  up to 24 months

Study Arms (2)

Prospective

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.

Historical

The historical cohort will be derived from the ITA.LI.CA database, which includes data on all consecutive patients with HCC who were managed within participating centers in Italy. The historical cohort will include patients from the ITA.LI.CA database who have active HCV infection who were not treated for HCV (IFN-based or DAA-based regimens) during the followup period, with initial HCC diagnosis BCLC Stage A, and subsequent successful treatment of HCC with curative therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• \- Liver transplantation since Screening

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Study Sites (62)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

University of California - Davis Clinical Trials

Sacramento, California, 95817, United States

Location

University of California - San Francisco

San Francisco, California, 94158, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Gastro Florida

Clearwater, Florida, 33762, United States

Location

University of Florida Hepatology Research at CTRB

Gainesville, Florida, 32610, United States

Location

University of Florida - Health Gastroenerology

Jacksonville, Florida, 32207, United States

Location

Schiff Center for Liver Diseases

Miami, Florida, 33136, United States

Location

Tampa General Medical Group

Tampa, Florida, 33606, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University Division of Gastroenterology and Hepatology

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, 39216, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Northwell Health - Center for Liver Disease

Manhasset, New York, 11030, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Carolinas HealthCare System Center for Liver Disease

Charlotte, North Carolina, 28204, United States

Location

Providence Health & Services Cancer Clinical Trials

Portland, Oregon, 97213, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Vanderbilt University Medical Center - GI Research Office

Nashville, Tennessee, 37212, United States

Location

Clinical Research Institute@ Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor Scott & White All Saints

Fort Worth, Texas, 76104, United States

Location

Research Specialists of Texas

Houston, Texas, 77030, United States

Location

Research Specialists of Texas

Houston, Texas, 77033, United States

Location

University of Virginia Transplant Center

Charlottesville, Virginia, 22908, United States

Location

Bon Secours Liver Institute of Virginia

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Wenatchee Valley Hospital & Clinics

Wenatchee, Washington, 98801, United States

Location

CHU de Nice - Hôpital L'Archet 2

Nice, France

Location

Hôpitaux Universitaires Paris Centre

Paris, France

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

A.O.U.P. di Palermo

Palermo, Italy

Location

Humanitas Mirasole IRCCS

Rozzano, Italy

Location

IRCCS "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, Italy

Location

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario Politècnic La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Hepatitis C; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 16, 2018
• Study Start: March 9, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); US (47); ES (5); IT (4); DE (4)