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 |
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.
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
sites
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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330 Brookline Ave
Boston, Massachusetts 02215
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
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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University of Michigan The University of Michigan was founded in 1817 as one of the...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
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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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
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
Charlotte, North Carolina 28204
Phone: 704-355-4875
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1653 W. Congress Parkway
Chicago, Illinois 60612
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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Dallas, Texas 75203
Phone: 214-947-4400
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1801 Inwood Rd
Dallas, Texas 75390
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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200 Hawkins Dr,
Iowa City, Iowa 52242
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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Nashville, Tennessee 37212
Phone: 615-343-5683
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333 East 38th Street
New York, New York 10016
New York, New York 10016
Phone: 646-501-4926
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630 W 168th St
New York, New York
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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Pasadena, California 91105
Principal Investigator: Edward Mena, MD
Phone: 626-795-5769
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3451 Walnut St
Philadelphia, Pennsylvania 19104
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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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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3700 O St NW
Washington, District of Columbia 20057
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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