Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

NCT03886077 | Completed FDA Drug

• 1 other identifier: 2-26-2019 1.2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-blinded cohort study that will assess the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy given post-discharge to HCV-negative recipients of HCV infected donors. Patients who meet entry criteria will be enrolled while on the transplant waitlist. At the time of transplant, some donors will be HCV positive / NAT positive and some will not be infected. Enrolled patients who receive an HCV negative donor will serve as contemporaneous controls. All study subjects who receive an HCV positive organ will be confirmed to have acquired HCV infection and genotype will be assessed prior to treatment with therapy.

Conditions

Coronary Artery Disease; Morality

Outcome Measures

Primary Outcomes (1)

• Sustained virological response at 12 weeks following therapy.

  12 weeks after the completion of drug that the patient no longer has Hepatitis C.

  12 weeks following completion of study drug.

Secondary Outcomes (1)

• Coronary allograft vasculopathy at 1 year post transplant.

  1 Year post heart transplant.

Study Arms (2)

Hepatitis C Negative Donor Hearts

Hearts for transplantation that are not infected with Hepatitis C. (Negative NAT)

Hepatitis C Infected Donor Hearts

Hearts for transplantation that are infected with Hepatitis C. (Positive NAT).

Drug: glecaprevir/pibrentasivir

Interventions

glecaprevir/pibrentasivir DRUG

12 weeks of oral open label glecaprevir/pibrentasivir (Dose 3 tablets daily per package label).

Hepatitis C Infected Donor Hearts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 subjects listed for cardiac transplantation will be enrolled. Patients will be educated about this protocol prior to transplant, and informed consent obtained. Enrolled subjects who receive a transplant with a NAT positive HCV infected donor will undergo NAT testing and surveillance post-operatively. In addition, patients who are offered an HCV infectious organ will be "re-consented" at the time of transplantation admission.

You may qualify if:

• Willing and capable of providing written informed consent
• Age ≥18 years
• On UNOS list as a candidate for heart transplant

You may not qualify if:

• Individuals under 18 years of age
• History of advanced liver disease, including active hepatitis B or C, detectable hepatitis B surface Ag, hepatitis B DNA, HCV RNA, or cirrhosis
• Pregnant individuals
• HIV antibody positive

Sponsors & Collaborators

• Sentara Norfolk General Hospital: lead

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

glecaprevir

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Amin Yehya, MD

  Sentara Norfolk General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Grants Manager

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: March 20, 2019
• Primary Completion: December 20, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)