Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

Duke University

Status and phase: Terminated; Phase 4

Conditions: Lung Transplant; Hepatitis C, Chronic

Treatments: Drug: Epclusa

Study type: Interventional

Funder types: Other

Identifiers

NCT03207399

Pro00074361

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Epclusa

Other group

Description:

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

Treatment:

Drug: Epclusa