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Hepatitis CNCT03707080

Direct Acting Antiviral-Post Authorization Safety Study

An observational study of Hepatitis C and Hepatocellular Carcinoma, run by Target PharmaSolutions, Inc. at 62 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Hepatocellular Carcinoma
How many people
42 participants
Where
62 sitesin 5 countries
Study dates
9 Mar 2018to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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

Trial locations and contacts

62 sites in 5 countries.

62 sites in 5 countries

United States47 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Carolinas HealthCare System Center for Liver Disease

    Charlotte, North Carolina, 28204

  • University of Virginia Transplant Center

    Charlottesville, Virginia, 22908

  • Northwestern University Division of Gastroenterology and Hepatology

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Gastro Florida

    Clearwater, Florida, 33762

  • Clinical Research Institute@ Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Baylor Scott & White All Saints

    Fort Worth, Texas, 76104

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Research Specialists of Texas

    Houston, Texas, 77030

  • Research Specialists of Texas

    Houston, Texas, 77033

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Southern Therapy and Advanced Research LLC

    Jackson, Mississippi, 39216

  • University of Florida - Health Gastroenerology

    Jacksonville, Florida, 32207

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Northwell Health - Center for Liver Disease

    Manhasset, New York, 11030

  • Schiff Center for Liver Diseases

    Miami, Florida, 33136

  • Vanderbilt University Medical Center - GI Research Office

    Nashville, Tennessee, 37212

  • Rutgers-Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • New York University Langone Health

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Stanford University

    Palo Alto, California, 94304

  • California Liver Research Institute

    Pasadena, California, 91105

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner University Medical Center

    Phoenix, Arizona, 85006

  • Providence Health & Services Cancer Clinical Trials

    Portland, Oregon, 97213

  • Bon Secours Liver Institute of Virginia

    Richmond, Virginia, 23226

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California - Davis Clinical Trials

    Sacramento, California, 95817

  • University of California - San Francisco

    San Francisco, California, 94158

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Saint Louis University

    St Louis, Missouri, 63110

  • Tampa General Medical Group

    Tampa, Florida, 33606

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

Other trials in United States

Spain5 sites

  • Hospital Puerta de Hierro Majadahonda

    Madrid

  • Clínica Universidad de Navarra

    Pamplona

  • Hospital Universitario Marques de Valdecilla

    Santander

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario Politècnic La Fe

    Valencia

Other trials in Spain

Germany4 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Magdeburg

    Magdeburg

Other trials in Germany

Italy4 sites

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

  • A.O.U.P. di Palermo

    Palermo

  • Humanitas Mirasole IRCCS

    Rozzano

  • IRCCS "Casa Sollievo della Sofferenza"

    San Giovanni Rotondo

Other trials in Italy

France2 sites

  • CHU de Nice - Hôpital L'Archet 2

    Nice

  • Hôpitaux Universitaires Paris Centre

    Paris

Other trials in France

About this 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

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.

Medical subject headings
Hepatitis C, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03707080
Study groupRoleWhat they receive
ProspectiveThe 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.
HistoricalThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to HCC recurrence - Prospective Cohort

    Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.

    Measured: up to 24 months

Secondary outcomes (3)

  1. 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.

    Measured: up to 24 months

  2. 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.

    Measured: up to 24 months

  3. 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.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start9 Mar 2018
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03707080
Sponsor's protocol ID
TARGET-HCC DAA-PASS
Status last verified
May 2021
First submitted
8 Oct 2018
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C and Hepatocellular Carcinoma, run by Target PharmaSolutions, Inc. at 62 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Spain, Germany, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to HCC recurrence - Prospective Cohort (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03707080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.

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