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

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ClinicalTrials.gov Identifier: NCT03523871
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of incidences of viremia after receiving a lung transplant from a donor who tests positive for hepatitis C [ Time Frame: 24 Months ]
    surveillance for the development of hepatitis C viremia post-transplant

  2. percentage of patients with sustained virologic response after treatment [ Time Frame: 24 Months ]
    HBV serologic testing to evaluate the presence of immunity to HBV or the evidence of prior infection with HBV.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523871


Contacts
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Contact: Cecilia Deterville, MS 646-315-3008 Cecilia.Deterville@nyumc.org
Contact: Elaina Weldon, MSN 646-385-0920 Elaina.Weldon@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Cecilia Deterville, MS    646-315-3008    Cecilia.Deterville@nyumc.org   
Principal Investigator: Luis Angel, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
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Principal Investigator: Luis Angel, MD New York University School of Medicine

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03523871     History of Changes
Other Study ID Numbers: 18-00091
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

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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:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections