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

Phase 4Active Not RecruitingNCT04508907

Mayo Clinic200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Hepatitis C Kidney Transplant; Complications Heart Transplant Infection

Interventions

MavyretDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Rate of prevention of HCV viremia in recipients of HCV viremic solid organs

The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.

Time frame: 3 months

Graft and patient survival

Study will assess the overall 1 year patient and graft survival.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.