The Hepatitis C Transplant Collaborative

Hepatitis C Clinical Trial

Official title:

Nationwide Hepatitis C NAT+ Cardiac Transplant Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04493385
• Other study ID #: 019-297
• Status: Recruiting
• Start date: September 16, 2019
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Baylor Research Institute
• Contact: Joost Felius, PhD
• Phone: 214-818-8943
• Email: Joost.Felius[@]BSWHEALTH.ORG
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.

Description:

Organ offers from donors with prior or chronic hepatitis C virus (HCV) exposure have been historically underutilized for orthotopic heart transplantation because of the post-transplantation risks [1, 2]. The use of HCV antibody-positive (Ab+) donors was associated with attenuated survival benefit after heart transplant and increased coronary allograft vasculopathy in the era before new highly effective direct-acting antiviral agents (DAAs) were developed [3-5]. These DAAs target multiple steps in the HCV replication life cycle [6]. Newer, well-tolerated, oral direct-acting antivirals (DAAs) have recently been transforming thoracic transplant outcomes after donor-derived HCV transmission. Moreover, now that HCV nucleic-acid testing (NAT), a polymerase chain reaction (PCR)-based approach to detecting viral activity, is widely available and used on all US donor organs, transplant centers have more relevant information about the donor, allowing better risk assessments.

As a result, the utilization of HCV NAT+ donor hearts for transplantation is rapidly gaining momentum, with the obvious benefits of an enlarged donor pool [7]. Appropriately, clinical safety trials are currently underway, including a multicenter effort led by the PI of this proposal. Moreover, since the last ~2 years many transplant centers across the nation have started transplanting HCV NAT+ donor organs as standard of care. We estimate that the number of HCV+ cardiac transplants is quickly outpacing the number of trial participants. Hence, it is imperative that safety assessments and risk analyses 'catch up with the real world'.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Recipient of a proven HCV NAT+ donor heart.

2. Re-transplant patients will be included.

Exclusion Criteria:

1. Multi-organ transplantation

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Transplant; Failure, Heart

Locations

Country	Name	City	State
United States	Baylor Scott & White Health Research Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (7)

Asselah T, Boyer N, Saadoun D, Martinot-Peignoux M, Marcellin P. Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives. Liver Int. 2016 Jan;36 Suppl 1:47-57. doi: 10.1111/liv.13027. — View Citation

Englum BR, Ganapathi AM, Speicher PJ, Gulack BC, Snyder LD, Davis RD, Hartwig MG. Impact of donor and recipient hepatitis C status in lung transplantation. J Heart Lung Transplant. 2016 Feb;35(2):228-35. doi: 10.1016/j.healun.2015.10.012. Epub 2015 Oct 9. — View Citation

Gasink LB, Blumberg EA, Localio AR, Desai SS, Israni AK, Lautenbach E. Hepatitis C virus seropositivity in organ donors and survival in heart transplant recipients. JAMA. 2006 Oct 18;296(15):1843-50. doi: 10.1001/jama.296.15.1843. — View Citation

Gottlieb RL, Hall SA. The New Direct Antiviral Agents and Hepatitis C in Thoracic Transplantation: Impact on Donors and Recipients. Curr Transplant Rep. 2018;5(2):145-152. doi: 10.1007/s40472-018-0192-y. Epub 2018 Apr 10. — View Citation

Haji SA, Starling RC, Avery RK, Mawhorter S, Tuzcu EM, Schoenhagen P, Cook DJ, Ratliff NB, McCarthy PM, Young JB, Yamani MH. Donor hepatitis-C seropositivity is an independent risk factor for the development of accelerated coronary vasculopathy and predicts outcome after cardiac transplantation. J Heart Lung Transplant. 2004 Mar;23(3):277-83. doi: 10.1016/S1053-2498(03)00148-7. — View Citation

Kim EY, Ko HH, Yoshida EM. A concise review of hepatitis C in heart and lung transplantation. Can J Gastroenterol. 2011 Aug;25(8):445-8. doi: 10.1155/2011/947838. — View Citation

Lee R, Kottilil S, Wilson E. Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy. Hepatol Int. 2017 Mar;11(2):161-170. doi: 10.1007/s12072-016-9776-8. Epub 2016 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation	To assess the current status of donor HCV NAT+ cardiac transplantation via retrospective data collection.	6.5 years
Primary	Failure versus Cure Rate for HCV NAT+ Heart Transplants	sustained viral response (SVR)-12 (cure-rate) for HCV negative recipient	6.5 years
Primary	Rate of Primary graft dysfunction (PGD)	Rate of Expected Post-Transplant Risks	30 days
Primary	1 year mortality	Number of deaths	1 Year
Primary	Cellular graft rejection rate	Graft rejection rate	6.5 years
Primary	Antibody Mediated Rejection rate	Graft rejection rate	6.5 years