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Direct Acting Antiviral-Post Authorization Safety Study

Sponsor
Target PharmaSolutions, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03707080
Collaborator
(none)
42
Enrollment
62
Locations
39.7
Actual Duration (Months)
0.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    42 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy
    Actual Study Start Date :
    Mar 9, 2018
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Jun 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center Phoenix Arizona United States 85006
    2 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    3 Norris Comprehensive Cancer Center Los Angeles California United States 90033
    4 Stanford University Palo Alto California United States 94304
    5 California Liver Research Institute Pasadena California United States 91105
    6 University of California - Davis Clinical Trials Sacramento California United States 95817
    7 University of California - San Francisco San Francisco California United States 94158
    8 Georgetown University Washington District of Columbia United States 20007
    9 Gastro Florida Clearwater Florida United States 33762
    10 University of Florida Hepatology Research at CTRB Gainesville Florida United States 32610
    11 University of Florida - Health Gastroenerology Jacksonville Florida United States 32207
    12 Schiff Center for Liver Diseases Miami Florida United States 33136
    13 Tampa General Medical Group Tampa Florida United States 33606
    14 Piedmont Atlanta Hospital Atlanta Georgia United States 30309
    15 Emory University Hospital Atlanta Georgia United States 30322
    16 Northwestern University Division of Gastroenterology and Hepatology Chicago Illinois United States 60611
    17 Rush University Medical Center Chicago Illinois United States 60612
    18 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    19 Tulane University School of Medicine New Orleans Louisiana United States 70112
    20 Mercy Medical Center Baltimore Maryland United States 21202
    21 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    22 University of Michigan Ann Arbor Michigan United States 48109
    23 Henry Ford Health System Detroit Michigan United States 48202
    24 Mayo Clinic Rochester Minnesota United States 55905
    25 Southern Therapy and Advanced Research LLC Jackson Mississippi United States 39216
    26 Saint Louis University Saint Louis Missouri United States 63110
    27 Rutgers-Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901
    28 Northwell Health - Center for Liver Disease Manhasset New York United States 11030
    29 New York University Langone Health New York New York United States 10016
    30 Weill Cornell Medical College New York New York United States 10021
    31 Columbia University Medical Center New York New York United States 10032
    32 Carolinas HealthCare System Center for Liver Disease Charlotte North Carolina United States 28204
    33 Providence Health & Services Cancer Clinical Trials Portland Oregon United States 97213
    34 Penn State Hershey Medical Center Hershey Pennsylvania United States 17033
    35 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    36 Medical University of South Carolina Charleston South Carolina United States 29403
    37 Vanderbilt University Medical Center - GI Research Office Nashville Tennessee United States 37212
    38 Clinical Research Institute@ Methodist Dallas Medical Center Dallas Texas United States 75203
    39 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    40 Baylor Scott & White All Saints Fort Worth Texas United States 76104
    41 Research Specialists of Texas Houston Texas United States 77030
    42 Research Specialists of Texas Houston Texas United States 77033
    43 University of Virginia Transplant Center Charlottesville Virginia United States 22908
    44 Bon Secours Liver Institute of Virginia Richmond Virginia United States 23226
    45 Virginia Commonwealth University Richmond Virginia United States 23298
    46 Harborview Medical Center Seattle Washington United States 98104
    47 Wenatchee Valley Hospital & Clinics Wenatchee Washington United States 98801
    48 CHU de Nice - Hôpital L'Archet 2 Nice France
    49 Hôpitaux Universitaires Paris Centre Paris France
    50 Charité - Universitätsmedizin Berlin Berlin Germany
    51 Universitätsklinikum Frankfurt Frankfurt Germany
    52 Universitätsklinikum Leipzig Leipzig Germany
    53 Universitätsklinikum Magdeburg Magdeburg Germany
    54 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy
    55 A.O.U.P. di Palermo Palermo Italy
    56 Humanitas Mirasole IRCCS Rozzano Italy
    57 IRCCS "Casa Sollievo della Sofferenza" San Giovanni Rotondo Italy
    58 Hospital Puerta de Hierro Majadahonda Madrid Spain
    59 Clínica Universidad de Navarra Pamplona Spain
    60 Hospital Universitario Marques de Valdecilla Santander Spain
    61 Hospital Universitario Virgen del Rocío Sevilla Spain
    62 Hospital Universitario Politècnic La Fe Valencia Spain

    Sponsors and Collaborators

    • Target PharmaSolutions, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Target PharmaSolutions, Inc.
    ClinicalTrials.gov Identifier:
    NCT03707080
    Other Study ID Numbers:
    • TARGET-HCC DAA-PASS
    First Posted:
    Oct 16, 2018
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis C
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Jul 6, 2021