Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

Therapuetic Areas:Immunology / Infectious Diseases
Age Range:Any
Start Date:July 15, 2018
End Date:January 2021

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PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver

In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with
livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be
given to the study subjects shortly after transplant to protect them from developing the
problems HCV can cause to the liver.

Inclusion Criteria:

- Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a
potential suitable living donor or for simultaneous liver kidney transplant;

- HCV non-infected at the time of transplant. Subjects who were previously HCV infected
but who have had documented SVR12 are eligible to participate;

- Agree to use two methods of birth control during the study;

- Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface
antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or
minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.

Exclusion Criteria:

- Donor and/or recipient HIV infection

- Subject pregnant or nursing

- Donor and/or recipient Hepatitis B surface antigen positive

- Kidney-pancreas transplant

- Single organ liver recipients who received hemodialysis for more than 7 days prior to
liver transplantation

- Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized
with panel reactive antibody > 80%; for single organ kidney transplant, subjects with
advanced liver fibrosis (Knodell stage 3) or cirrhosis

- Individuals being treated with and needing to continue rifabutin, rifampin,
carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum
perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton
pump inhibitors (See Concomitant Medications).

- Individuals treated with amiodarone within 42 days of organ transplant.
We found this trial at
Dallas, Texas 75246
Principal Investigator: Joanna Bayer,, MD
Phone: 214-818-7876
Dallas, TX
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Elizabeth Verna, MD
Phone: 212-305-3839
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
New York, NY
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Atlanta, Georgia
Principal Investigator: Raymond Rubin, MD
Phone: 404-605-4618
Atlanta, GA
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13001 E. 17th Pl
Aurora, Colorado 80045
Principal Investigator: James Burton, MD
Phone: 303-724-8892
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
Aurora, CO
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: David Victor, MD
Phone: 713-441-6316
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
Houston, TX
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San Francisco, California 94143
Principal Investigator: Norah Terrault, MD
Phone: 415-514-3274
San Francisco, CA
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