Expanding the Pool in Lung Transplantation

NCT03377478 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STUDY19030435
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Lung Transplant

Outcome Measures

Primary Outcomes (4)

• HCV Viremia

  Incidence of HCV Viremia

  at 2 years

• Seroconversion

  Rate of HCV seroconversion

  at 2 years

• Liver Function Testing

  Assessment of Hepatic function

  at 2 years

• Survival

  Survival rates

  at 2 years

Secondary Outcomes (2)

• Rejection

  at 2 years

• Waitlist

  at 2 years

Study Arms (1)

Lung Transplant

EXPERIMENTAL

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

Interventions

Epclusa DRUG

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

Also known as: Procedure, Sofosbuvir/velpatasvir

Lung Transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pablo Sanchez: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Sofosbuvir
• Drug Information

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination; Methods

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Pablo Sanchez, MD

  Assistant Professor of Surgery/University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 19, 2017
• Study Start: July 30, 2019
• Primary Completion: September 21, 2021
• Study Completion: April 1, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)