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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

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date May 23, 2018
Actual Study Start Date  ICMJE May 12, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
percentage of patients with sustained virologic response after treatment [ Time Frame: 24 Months ]
surveillance for the development of hepatitis C viremia post-transplant followed by percentage of sustained virologic response post treatment
Change History Complete list of historical versions of study NCT03523871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE Drug: Mavyret
Patients will be on 8 weeks of Mavyret
Other Names:
  • pibrentasvir
  • glecaprevir
Study Arms  ICMJE 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.
Intervention: Drug: Mavyret
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cecilia Deterville, MS 646-315-3008 Cecilia.Deterville@nyumc.org
Contact: Elaina Weldon, MSN 646-385-0920 Elaina.Weldon@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03523871
Other Study ID Numbers  ICMJE 18-00091
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York University School of Medicine
Study Sponsor  ICMJE New York University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luis Angel, MD New York University School of Medicine
PRS Account New York University School of Medicine
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP