NCT04596475

Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor to HCVNegative Organ Transplant Recipient - Pilot Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).

Conditions

• Hepatitis C
• Hepatitis C Virus Infection, Response to Therapy of

Interventions

Type	Name	Description
DRUG	glecaprevir/pibrentasvir (GLE/PIB)	The study intervention consists of a single daily dose of GLE/PIB 100/40 mg (one dose consists of 3 tablets) administered orally; or crushed and administered via a feeding tube if participant is unable to swallow by mouth, for example in the immediate post-operative period. First dose will be administered in the pre-operative period within 4 hours of surgery followed by once daily doses for 7 days total.

Timeline

• Start date: 2021-05-28
• Primary completion: 2022-04-21
• Completion: 2022-04-21
• First posted: 2020-10-22
• Last updated: 2022-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study