Expanding the Pool in Lung Transplantation

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377478
• Other study ID #: STUDY19030435
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: December 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 1, 2022
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Lung Transplant

Intervention

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

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pablo Sanchez

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV Viremia	Incidence of HCV Viremia	at 2 years
Primary	Seroconversion	Rate of HCV seroconversion	at 2 years
Primary	Liver Function Testing	Assessment of Hepatic function	at 2 years
Primary	Survival	Survival rates	at 2 years
Secondary	Rejection	The incidence of rejection	at 2 years
Secondary	Waitlist	Time on waitlist will be assessed	at 2 years

External Links

•   Drug Information
•   Sofosbuvir