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

NCT03523871 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-00091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Post Lung Transplant Patients

EXPERIMENTAL

The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.

Drug: Mavyret

Interventions

Mavyret DRUG

Patients will be on 8 weeks of Mavyret

Also known as: pibrentasvir, glecaprevir

Post Lung Transplant Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

glecaprevir and pibrentasvir; pibrentasvir; glecaprevir

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

Results Point of Contact

• Title: Luis Angel, MD
• Organization: NYU Langone Health

Luis.Angel@nyulangone.org

646-501-0119

Study Officials

• Luis Angel, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 14, 2018
• Study Start: May 12, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-09

Locations

US (1)