Direct Acting Antiviral-Post Authorization Safety Study
NCT ID: NCT03707080
Last Updated: 2021-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2018-03-09
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
\- Liver transplantation since Screening
18 Years
ALL
No
Sponsors
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Target PharmaSolutions, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner University Medical Center
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
California Liver Research Institute
Pasadena, California, United States
University of California - Davis Clinical Trials
Sacramento, California, United States
University of California - San Francisco
San Francisco, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Gastro Florida
Clearwater, Florida, United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, United States
University of Florida - Health Gastroenerology
Jacksonville, Florida, United States
Schiff Center for Liver Diseases
Miami, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University Division of Gastroenterology and Hepatology
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States
Saint Louis University
St Louis, Missouri, United States
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Northwell Health - Center for Liver Disease
Manhasset, 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
Columbia University Medical Center
New York, New York, United States
Carolinas HealthCare System Center for Liver Disease
Charlotte, North Carolina, United States
Providence Health & Services Cancer Clinical Trials
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee, United States
Clinical Research Institute@ Methodist Dallas Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor Scott & White All Saints
Fort Worth, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
University of Virginia Transplant Center
Charlottesville, Virginia, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
CHU de Nice - Hôpital L'Archet 2
Nice, , France
Hôpitaux Universitaires Paris Centre
Paris, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsklinikum Magdeburg
Magdeburg, , Germany
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, , Italy
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
Seville, , Spain
Hospital Universitario Politècnic La Fe
Valencia, , Spain
Countries
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Other Identifiers
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TARGET-HCC DAA-PASS
Identifier Type: -
Identifier Source: org_study_id
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