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Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant (PRO-ACT:)

Primary Purpose

Hepatitis C, Transplantation Disease Transmission

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sofosbuvir/Velpatasvir
Sofosbuvir/Velpatasvir/Voxilaprevir
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco
  • University of Colorado Denver
  • Piedmont Research Institute
  • Columbia University
  • Baylor University Medical Center - Dallas
  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Single Arm: Sofosbuvir/Velpatasvir Dosage: 400mg/100mg. Once daily for 12 weeks.

Outcomes

Primary Outcome Measures

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 <LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as > 1 log increase in viral RNA after treatment week 1. 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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 13, 2018
Last Updated
February 10, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03619837
Brief Title
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
Acronym
PRO-ACT:
Official Title
PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
December 21, 2019 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Transplantation Disease Transmission

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Single Arm: Sofosbuvir/Velpatasvir Dosage: 400mg/100mg. Once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir/Velpatasvir
Intervention Description
Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir/Velpatasvir/Voxilaprevir
Intervention Description
Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir. Dosage: 400mg/100mg/100mg daily for 12 weeks.
Primary Outcome Measure Information:
Title
Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
Description
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 <LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as > 1 log increase in viral RNA after treatment week 1. 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.
Time Frame
12 weeks after end of treatment
Secondary Outcome Measure Information:
Title
Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment
Description
1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure.
Time Frame
12 weeks after start of treatment
Other Pre-specified Outcome Measures:
Title
Survival Rate of Patients and Their Allografts 6 Months Post Transplant
Description
Graft and patient survival at 24 weeks after transplant
Time Frame
6 months from time of liver transplant

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Niemann, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Piedmont Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Baylor University Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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