A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04508907

Enrollment

227

Registered

2020-08-11

Start date

2020-09-10

Completion date

2025-11-01

Last updated

2026-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Kidney Transplant; Complications, Heart Transplant Infection

Brief summary

This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.

Interventions

DRUGMavyret

Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection * Willing to accept and consent for accepting hepatitis C positive graft

Exclusion criteria

* Existing chronic liver disease (liver cirrhosis) * Concomitant infection with HIV or Chronic hepatitis B * Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection * Pregnancy (Pregnant patients do not undergo solid organ transplants)

Design outcomes

Primary

Measure	Time frame	Description
Rate of Prevention of HCV Viremia in Recipients of HCV Viremic Solid Organs	3 months	The percentage of patients who did not become HCV viremic using this preemptive treatment protocol.
Graft and Patient Survival	1 year	The number of subjects alive at 1-year and the number of subjects with a functioning transplanted organ (graft survival) at 1-year.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBashar A Aqel

Mayo Clinic

Baseline characteristics

Characteristic	—
Age, Continuous	60 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	227 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants
Race (NIH/OMB) Asian	24 Participants
Race (NIH/OMB) Black or African American	39 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants
Race (NIH/OMB) White	116 Participants
Region of Enrollment United States	227 participants
Sex: Female, Male Female	75 Participants
Sex: Female, Male Male	152 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	8 / 227
other Total, other adverse events	0 / 227
serious Total, serious adverse events	0 / 227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 30, 2026