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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT04596475
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • glecaprevir/pibrentasvir (GLE/PIB) — DRUG
    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.

Study Details

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).

Key Dates

Start date
May 28, 2021
Status verified
May 2022
Primary completion
Apr 21, 2022
Completion
Apr 21, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment Arm

Primary Outcome Measure

Percentage of participants with Sustained Virological Response [ Time Frame: 91 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92037-

Find similar trials in San Diego, CA

By research site
University of California San Diego· San Diego, CA

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