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

Mayo Clinic

Status and phase: Active, not recruiting; Phase 4

Conditions: Hepatitis C; Kidney Transplant; Complications; Heart Transplant Infection

Treatments: Drug: Mavyret

Study type: Interventional

Funder types: Other

Identifiers

NCT04508907

20-001964

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Arm 1: Pre-emptive Treatment Arm

Experimental group

Description:

Single arm study were all recipients of HCV viremic organs will receive combination therapy.

Treatment:

Drug: Mavyret