Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03207399
• Other study ID #: Pro00074361
• Status: Terminated
• Phase: Phase 4
• Start date: September 15, 2017
• Est. completion date: March 25, 2019

Study information

• Verified date: August 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic
• Lung Transplant

Intervention

Drug:
• Epclusa
Patients will be treated with this drug for 12 weeks post lung transplant.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA	Adverse events resulting in discontinuation of EPCLUSA	1 year
Primary	Number of Patients Eligible for EPCLUSA Treatment	Eligibility for EPCLUSA treatment within 12 months of lung transplant	within 12 months of lung transplant
Secondary	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
Secondary	Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy	Adverse events requiring temporary interruption in EPCLUSA therapy	1 year
Secondary	Patient Survival	90-day post transplant patient survival	90 days post-transplant
Secondary	Patient Survival	1 year post transplant patient survival	1 year post-tranplant
Secondary	Patient Survival	90-day post transplant patient survival in recipients of HCV NAT positive donor organ	90 days post-transplant
Secondary	Patient Survival	1 year post transplant patient survival in recipients of HCV NAT positive donor organ	1 year post-transplant