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

NCT04596475 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-05-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2022-04-21
Completion
2022-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596475 on ClinicalTrials.gov