Trial Outcomes & Findings for A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret (NCT NCT03523871)

NCT ID: NCT03523871

Last Updated: 2021-09-05

Results Overview

Surveillance for the development of hepatitis C viremia post-transplant

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 24 Months
• Results posted on: 2021-09-05

Participant Flow

Participant milestones

Measure	Post Lung Transplant Patients 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. Mavyret: Patients will be on 8 weeks of Mavyret
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Post Lung Transplant Patients 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. Mavyret: Patients will be on 8 weeks of Mavyret
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Post Lung Transplant Patients n=20 Participants 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. Mavyret: Patients will be on 8 weeks of Mavyret
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Surveillance for the development of hepatitis C viremia post-transplant

Outcome measures

Measure	Post Lung Transplant Patients n=20 Participants 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. Mavyret: Patients will be on 8 weeks of Mavyret
Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C	16 incidences

PRIMARY outcome

Timeframe: 24 Months

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

Outcome measures

Measure	Post Lung Transplant Patients n=20 Participants 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. Mavyret: Patients will be on 8 weeks of Mavyret
Number of Patients With Sustained Virologic Response After Treatment	20 Participants

Adverse Events

Post Lung Transplant Patients

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Post Lung Transplant Patients n=20 participants at risk 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. Mavyret: Patients will be on 8 weeks of Mavyret
Respiratory, thoracic and mediastinal disorders Death	5.0% 1/20 • Number of events 1 • 24 months

Other adverse events

Measure	Post Lung Transplant Patients n=20 participants at risk 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. Mavyret: Patients will be on 8 weeks of Mavyret
Respiratory, thoracic and mediastinal disorders Increased shortness of breath	5.0% 1/20 • 24 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.0% 1/20 • 24 months
Gastrointestinal disorders Abdominal Pain	5.0% 1/20 • 24 months
Gastrointestinal disorders Diarrhea	5.0% 1/20 • 24 months
Renal and urinary disorders Acute Renal Failure	5.0% 1/20 • 24 months
Musculoskeletal and connective tissue disorders Right Hip Fracture	5.0% 1/20 • 24 months

Additional Information

Luis Angel, MD

NYU Langone Health

Phone: 646-501-0119

Email: Luis.Angel@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place