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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03523871
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 27.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Mavyret	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 12, 2018
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Mavyret; Patients will be on 8 weeks of Mavyret; Other Names: pibrentasvir glecaprevir

Outcome Measures

Primary Outcome Measures

1. Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C [24 Months]

   Surveillance for the development of hepatitis C viremia post-transplant

2. Number of Patients With Sustained Virologic Response After Treatment [24 Months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Luis Angel, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 14, 2019

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03523871
• Other Study ID Numbers: 18-00091
• First Posted: May 14, 2018
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis

Study Results

Participant Flow

Arm/Group Title	Post Lung Transplant Patients
Arm/Group Description	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
Period Title: Overall Study
STARTED	20
COMPLETED	19
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Post Lung Transplant Patients
Arm/Group Description	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 Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 20%
Male	16 80%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 20%
Not Hispanic or Latino	16 80%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 10%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 5%
White	13 65%
More than one race	0 0%
Unknown or Not Reported	4 20%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C
Description	Surveillance for the development of hepatitis C viremia post-transplant
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Post Lung Transplant Patients
Arm/Group Description	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
Measure Participants	20
Number [incidences]	16

2. Primary Outcome

Title	Number of Patients With Sustained Virologic Response After Treatment
Description	HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Post Lung Transplant Patients
Arm/Group Description	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
Measure Participants	20
Count of Participants [Participants]	20 100%

Adverse Events

Time Frame	24 months
Arm/Group Title	Post Lung Transplant Patients
Arm/Group Description	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
All Cause Mortality
	Post Lung Transplant Patients
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Serious Adverse Events
	Post Lung Transplant Patients
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Death	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Post Lung Transplant Patients
	Affected / at Risk (%)	# Events
Total	4/20 (20%)
Gastrointestinal disorders
Abdominal Pain	1/20 (5%)
Diarrhea	1/20 (5%)
Musculoskeletal and connective tissue disorders
Right Hip Fracture	1/20 (5%)
Renal and urinary disorders
Acute Renal Failure	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Increased shortness of breath	1/20 (5%)
Pneumothorax	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.