Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study

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.

Study Overview

• Status: Terminated
• Conditions: Hepatitis C, Chronic; Lung Transplant
• Intervention / Treatment: Drug: Epclusa

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Epclusa; Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.	Drug: Epclusa; Patients will be treated with this drug for 12 weeks post lung transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA	Adverse events resulting in discontinuation of EPCLUSA	1 year
Number of Patients Eligible for EPCLUSA Treatment	Eligibility for EPCLUSA treatment within 12 months of lung transplant	within 12 months of lung transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum HCV RNA Levels	Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA	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	1 year
Patient Survival	90-day post transplant patient survival	90 days post-transplant
Patient Survival	1 year post transplant patient survival	1 year post-tranplant
Patient Survival	90-day post transplant patient survival in recipients of HCV NAT positive donor organ	90 days post-transplant
Patient Survival	1 year post transplant patient survival in recipients of HCV NAT positive donor organ	1 year post-transplant

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Omar Mohamedaly, MD, Duke Heath

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2017
• Primary Completion (ACTUAL): March 25, 2019
• Study Completion (ACTUAL): March 25, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir-velpatasvir drug combination
• Other Study ID Numbers: Pro00074361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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