Clinical trial NCT03619837: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
Official title: PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Transplantation Disease Transmission
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
timeFrame: 12 weeks after end of treatment
Secondary outcomes:
measure: Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment
timeFrame: 12 weeks after start of treatment
Other outcomes:
measure: Survival Rate of Patients and Their Allografts 6 Months Post Transplant
timeFrame: 6 months from time of liver transplant
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Piedmont Research Institute
state: Georgia
city: New York
country: United States
facility: Columbia University
state: New York
city: Dallas
country: United States
facility: Baylor University Medical Center - Dallas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Claus Niemann, MD
role: PRINCIPAL_INVESTIGATOR
References: