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
	
								Dallas, Texas 75203			
	
			
					Phone: 214-947-4400
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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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									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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		Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...  
  
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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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