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

Hepatitis C Clinical Trial

— PRO-ACT:  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619837
• Other study ID #: 18-24323
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2018
• Est. completion date: August 13, 2020

Study information

• Verified date: February 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 13, 2020
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• Transplantation Disease Transmission

Intervention

Drug:
• Sofosbuvir/Velpatasvir
Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.
• Sofosbuvir/Velpatasvir/Voxilaprevir
Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir. Dosage: 400mg/100mg/100mg daily for 12 weeks.

Locations

Country	Name	City	State
United States	Piedmont Research Institute	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Baylor University Medical Center - Dallas	Dallas	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Columbia University	New York	New York
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survival Rate of Patients and Their Allografts 6 Months Post Transplant	Graft and patient survival at 24 weeks after transplant	6 months from time of liver transplant
Primary	Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)	The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA < lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant.	12 weeks after end of treatment
Secondary	Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment	1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure.	12 weeks after start of treatment