NCT03523871

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

Completed Phase 2 Results posted Last updated 5 September 2021

What this trial tests

Phase 2 trial testing Mavyret in Hepatitis C in 20 participants. Completed in 1 September 2020.

Timeline

12 May 2018

Primary endpoint
1 September 2020

1 September 2020

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	12 May 2018
Primary completion	1 September 2020
Estimated completion	1 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Mavyret (GLECAPREVIR) — full drug profile →

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 70, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C Primary · 24 Months

Surveillance for the development of hepatitis C viremia post-transplant

Group	Value	95% CI
Post Lung Transplant Patients	16

Number of Patients With Sustained Virologic Response After Treatment Primary · 24 Months

HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.

Group	Value	95% CI
Post Lung Transplant Patients	20

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Post Lung Transplant Patients

Serious: 1/20 (5%)

Deaths: 1/20

Serious adverse events (1 terms)

Reaction	System	Post Lung Transplant Patie…
Death	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Post Lung Transplant Patie…
Increased shortness of breath	Respiratory, thoracic and mediastinal disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Acute Renal Failure	Renal and urinary disorders	—
Right Hip Fracture	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03523871 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections.
   Stewart ZA, Stern J, Ali NM, Kalia HS, et al · · 2021 · cited 8× · PMID 34514117 · DOI 10.1097/txd.0000000000001222