A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

Hepatitis C Clinical Trial

Official title:

A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523871
• Other study ID #: 18-00091
• Status: Completed
• Phase: Phase 2
• Start date: May 12, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Recipient criteria:

• Listed for an isolated lung transplant at NYU Langone Health

• Between 18-70 years of age

• Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation

• No active illicit substance abuse

• Weight at least 40kg

• Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage

• Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange

• Able and willing to provide informed consent

Donor criteria:

• Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody

• Donor lung meets standard NYU Langone Health clinical criteria for procurement

Exclusion Criteria:

Recipient criteria:

• HIV positive

• HCV RNA positive or history of previously treated HCV

• Evidence of active hepatitis B infection or on active antiviral treatment for HBV

• Pregnant or nursing (lactating) women

• Use of strong CYP3A inducers

• Requires multi-organ transplant

Donor criteria:

• Confirmed HIV positive

• Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable Hepatitis B virus DNA)

• Known previously failed treatment for HCV

• Donor age >60 years

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Mavyret
Patients will be on 8 weeks of Mavyret

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C	Surveillance for the development of hepatitis C viremia post-transplant	24 Months
Primary	Number of Patients With Sustained Virologic Response After Treatment	HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.	24 Months