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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04508907

Enrollment

200

Registered

2020-08-11

Start date

2020-09-10

Completion date

2026-11-01

Last updated

2025-12-17

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 study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.
Graft and patient survival	1 year	Study will assess the overall 1 year patient and graft survival.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026