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Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

Primary Purpose

Hepatitis C, Chronic, Lung Transplant

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epclusa
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • HCV RNA >= 10^3 IU/ml at screening
  • Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
  • HCV Genotype 1, 2, 3, 4, 5 or 6
  • Otherwise eligible for lung transplant at study site

Exclusion Criteria:

  • Age <18

  • Treatment with any of the following agents:

    • Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL
    • Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
    • Rifabutin, rifampin or rifapentine
    • HIV regimens containing tenofovir or tipranavir/ritonavir
    • St John's wort
    • PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole
    • Modafinil
  • Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
  • Hepatitis B surface antigen positive
  • History of hepatic encephalopathy or variceal hemorrhage

  • Abnormal hematological and biochemical parameters, including:

    • Hemoglobin <8g/dL
    • Platelets <= 50,000/mm^3
    • ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase >=10 times ULN
    • Total bilirubin >3mg/dL
    • Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min
  • Pregnant women or women planning to become pregnant
  • Women or are breastfeeding
  • Active or recent history (<=1 year) of drug or alcohol abuse

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Epclusa

Arm Description

Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.

Outcomes

Primary Outcome Measures

Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
Adverse events resulting in discontinuation of EPCLUSA
Number of Patients Eligible for EPCLUSA Treatment
Eligibility for EPCLUSA treatment within 12 months of lung transplant

Secondary Outcome Measures

Change in Serum HCV RNA Levels
Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
Adverse events requiring temporary interruption in EPCLUSA therapy
Patient Survival
90-day post transplant patient survival
Patient Survival
1 year post transplant patient survival
Patient Survival
90-day post transplant patient survival in recipients of HCV NAT positive donor organ
Patient Survival
1 year post transplant patient survival in recipients of HCV NAT positive donor organ

Full Information

First Posted
June 30, 2017
Last Updated
August 20, 2019
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03207399
Brief Title
Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
Official Title
Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Enrollment terminated due to not having any other eligible participants.
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic, Lung Transplant

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Epclusa
Arm Type
Other
Arm Description
Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.
Intervention Type
Drug
Intervention Name(s)
Epclusa
Intervention Description
Patients will be treated with this drug for 12 weeks post lung transplant.
Primary Outcome Measure Information:
Title
Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
Description
Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Time Frame
12 weeks
Title
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
Description
Adverse events resulting in discontinuation of EPCLUSA
Time Frame
1 year
Title
Number of Patients Eligible for EPCLUSA Treatment
Description
Eligibility for EPCLUSA treatment within 12 months of lung transplant
Time Frame
within 12 months of lung transplant
Secondary Outcome Measure Information:
Title
Change in Serum HCV RNA Levels
Description
Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA
Time Frame
12, 24, and 48 weeks after initiation of EPCLUSA
Title
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
Description
Adverse events requiring temporary interruption in EPCLUSA therapy
Time Frame
1 year
Title
Patient Survival
Description
90-day post transplant patient survival
Time Frame
90 days post-transplant
Title
Patient Survival
Description
1 year post transplant patient survival
Time Frame
1 year post-tranplant
Title
Patient Survival
Description
90-day post transplant patient survival in recipients of HCV NAT positive donor organ
Time Frame
90 days post-transplant
Title
Patient Survival
Description
1 year post transplant patient survival in recipients of HCV NAT positive donor organ
Time Frame
1 year post-transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HCV RNA >= 10^3 IU/ml at screening Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening HCV Genotype 1, 2, 3, 4, 5 or 6 Otherwise eligible for lung transplant at study site Exclusion Criteria: Age <18 Treatment with any of the following agents: Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL Carbamazepine, phenytoin, phenobarbital, oxcarbazepine Rifabutin, rifampin or rifapentine HIV regimens containing tenofovir or tipranavir/ritonavir St John's wort PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole Modafinil Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance Hepatitis B surface antigen positive History of hepatic encephalopathy or variceal hemorrhage Abnormal hematological and biochemical parameters, including: Hemoglobin <8g/dL Platelets <= 50,000/mm^3 ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase >=10 times ULN Total bilirubin >3mg/dL Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min Pregnant women or women planning to become pregnant Women or are breastfeeding Active or recent history (<=1 year) of drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Mohamedaly, MD
Organizational Affiliation
Duke Heath
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

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