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HCV Positive Heart Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382847
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE December 19, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date August 27, 2019
Actual Study Start Date  ICMJE January 5, 2018
Estimated Primary Completion Date April 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
Sustained virologic response after treatment [ Time Frame: 1 year ]
Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03382847 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 HCV Positive Heart Donors
Official Title  ICMJE A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Heart Transplant Recipients With Post-transplant Treatment of Hepatitis C Viremia With Mavyret
Brief Summary Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Combination Product: Transplant with HCV positive donor, followed by surveillance and treatment of viremia
Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs
Study Arms  ICMJE Experimental: Intervention arm
HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment.
Intervention: Combination Product: Transplant with HCV positive donor, followed by surveillance and treatment of viremia
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 26, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2017)
10
Estimated Study Completion Date  ICMJE April 25, 2020
Estimated Primary Completion Date April 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Listed for an isolated heart transplant at NYU Langone Health
  • 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 50kg
  • 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

Exclusion Criteria:

  • HIV positive
  • HCV RNA positive or history of previously treated HCV
  • Hepatitis B surface antigen positive or on active antiviral treatment for HBV
  • Pregnant or nursing (lactating) women
  • Use of strong CYP3A inducers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03382847
Other Study ID Numbers  ICMJE 17-01775
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alex Reyentovich, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date August 2019

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