Direct Acting Antiviral-Post Authorization Safety Study



Status:Recruiting
Conditions:Liver Cancer, Cancer, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:March 9, 2018
End Date:December 31, 2022
Contact:Mara Grbic, MPH
Email:mgrbic@targetpharmasolutions.com
Phone:984-234-0268

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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.


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
We found this trial at
43
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-632-1129
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Phone: 501-686-5177
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 877-758-2626
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30309
Phone: 404-605-2347
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Phone: 404-712-8936
Emory University Hospital As the largest health care system in Georgia and the only health...
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Phone: 410-843-2075
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-876-8439
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1000 Blythe Boulevard
Charlotte, North Carolina 28204
Phone: 704-355-4875
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Charlottesville, Virginia 22908
Phone: 434-924-6183
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-3049
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Clearwater, Florida 33762
Phone: 727-345-0005
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Dallas, Texas 75203
Phone: 214-947-4400
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-645-9748
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Fort Worth, Texas 76104
Phone: 817-922-2571
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Gainesville, Florida 32610
Phone: 352-273-7279
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-353-4574
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jackson, Mississippi 39216
Phone: 769-251-5674
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Jacksonville, Florida 32207
Phone: 904-633-0070
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Los Angeles, California 90033
Phone: 323-409-4355
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Manhasset, New York 11030
Phone: 516-562-2082
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Miami, Florida 33136
Phone: 305-243-4649
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Nashville, Tennessee 37212
Phone: 615-343-5683
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New Brunswick, New Jersey 08903
Phone: 732-235-3383
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New Orleans, Louisiana 70112
Phone: 504-988-6902
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333 East 38th Street
New York, New York 10016
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New York, New York 10021
Phone: 646-962-2085
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-3839
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Palo Alto, California 94304
Phone: 650-721-4288
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Pasadena, California 91105
Principal Investigator: Edward Mena, MD
Phone: 626-795-5769
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-360-0921
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Portland, Oregon 97213
Phone: 503-215-2614
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Richmond, Virginia 23298
(804) 828-0100
Phone: 804-628-9395
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, Virginia 23226
Phone: 757-947-3191
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Rochester, Minnesota 55905
Phone: 507-538-0097
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Sacramento, California 95817
Phone: 916-734-8246
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Saint Louis, Missouri 63110
Phone: 314-577-8854
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Phone: 206-744-3402
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Tampa, Florida 33606
Phone: 813-844-4006
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Phone: 202-444-1085
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Wenatchee, Washington 98801
Phone: 509-664-4868
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