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Expanding the Pool in Lung Transplantation

Sponsor
Pablo Sanchez (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03377478
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
78.1
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
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
Actual Study Start Date :
Jul 30, 2019
Actual Primary Completion Date :
Sep 21, 2021
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HCV Viremia [at 2 years]

      Incidence of HCV Viremia

    2. Seroconversion [at 2 years]

      Rate of HCV seroconversion

    3. Liver Function Testing [at 2 years]

      Assessment of Hepatic function

    4. Survival [at 2 years]

      Survival rates

    Secondary Outcome Measures

    1. Rejection [at 2 years]

      The incidence of rejection

    2. Waitlist [at 2 years]

      Time on waitlist will be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UPMC Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • Pablo Sanchez

    Investigators

    • Principal Investigator: Pablo Sanchez, MD, Assistant Professor of Surgery/University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pablo Sanchez, Assistant Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT03377478
    Other Study ID Numbers:
    • STUDY19030435
    First Posted:
    Dec 19, 2017
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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:
    Hepatitis A
    Hepatitis C
    Hepatitis
    Sofosbuvir
    Sofosbuvir-velpatasvir drug combination
    Velpatasvir

    Study Results

    No Results Posted as of Oct 5, 2021