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Expanding the Pool in Lung Transplantation

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ClinicalTrials.gov Identifier: NCT03377478
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan D'Cunha, University of Pittsburgh

Brief Summary:
To perform a study (100 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.

Condition or disease Intervention/treatment Phase
Hepatits C Lung Transplant Drug: Epclusa Phase 1

Detailed Description:

The investigators are proposing a proof of concept study 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 100 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Lung Transplant
Patients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir).
Drug: Epclusa
Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
Other Names:
  • Procedure
  • Sofosbuvir/velpatasvir




Primary Outcome Measures :
  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 Outcome Measures :
  1. Rejection [ Time Frame: at 2 years ]
    The incidence of rejection

  2. Waitlist [ Time Frame: at 2 years ]
    Time on waitlist will be assessed



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377478


Contacts
Contact: Jonathan D'Cunha, MD, PhD 412-648-6315 dcunhaj@upmc.edu
Contact: Pablo Sanchez, MD 412-648-6315 sanchezpg@upmc.edu

Locations
United States, Pennsylvania
UPMC Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jonathan D'Cunha, MD, PhD    412-648-6315    dcunhaj@upmc.edu   
Contact: Pablo Sanchez, MD    412-648-6315    sanchezpg@upmc.edu   
Sponsors and Collaborators
Jonathan D'Cunha
Investigators
Principal Investigator: Jonathan D'Cunha, MD, PhD Associate Professor of Surgery/University of Pittsburgh

Additional Information:
Responsible Party: Jonathan D'Cunha, Associate Professor of Cardiothoracic Surgery; Chief, Division of Lung Transplantation/Lung Failure, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03377478     History of Changes
Other Study ID Numbers: PRO17040272
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents