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OpenTrials
Completed

NCT Number: NCT03377478

Expanding the Pool in Lung Transplantation

To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.

This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who sign the informed consent for this study
  • Patients whom agree to receive a PHS high risk organ
  • Patients listed for heart transplantation
  • Age 18-65

Exclusion criteria

  • Patients who do not sign informed consent for this study
  • HIV Seropositivity
  • HBV Seropositivity (HBcAb and/or HBsAg positive)
  • Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT)
  • Acute or chronic renal insufficiency (creatinine clearance <50 ml/min) or history of dialysis
  • Patients on ECMO
  • Respiratory insufficiency requiring mechanical respiratory support (ventilator, BiPAP)
  • Liver insufficiency
  • Prior history of hepatitis C
  • Allergy to Sofosbuvir/velpatasvir
  • Pregnancy

Treatment and study plan

Epclusa

Drug

Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.

Other names: Procedure, Sofosbuvir/velpatasvir

Primary outcomes

  1. HCV Viremia

    Time frame: at 2 years

    Incidence of HCV Viremia

  2. Seroconversion

    Time frame: at 2 years

    Rate of HCV seroconversion

  3. Liver Function Testing

    Time frame: at 2 years

    Assessment of Hepatic function

  4. Survival

    Time frame: at 2 years

    Survival rates

Secondary outcomes

  1. Rejection

    Time frame: at 2 years

    The incidence of rejection

  2. Waitlist

    Time frame: at 2 years

    Time on waitlist will be assessed

Sponsors and collaborators

Lead sponsor

Pablo Sanchez

Other

Registry information

Official study title

Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 19, 2017
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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