Preemptive Mavyret Therapy for Hepatitis C in Organ Transplant Recipients
Recruiting at 1 trial location
BA
Overseen byBashar A Aqel
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial is testing if using two medicines together can stop Hepatitis C from spreading to people who get an organ transplant from a donor with Hepatitis C. The goal is to protect the new organ recipient from getting infected by the virus.
Research Team
BA
Bashar A Aqel
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for kidney, heart, lung, or pancreas transplant patients without chronic hepatitis C. Participants must be willing to accept a graft from a donor with hepatitis C and understand the risks of acquiring HCV infection. Those with chronic liver disease, pregnant women, or individuals with HIV or chronic hepatitis B cannot join.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)
Pregnancy (Pregnant patients do not undergo solid organ transplants)
You or someone taking care of you do not understand or accept the risk of getting Hepatitis C during the course of the trial.
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Treatment Details
Interventions
- Mavyret (Anti-viral)
Trial OverviewThe study tests the effectiveness of Mavyret in preventing the transmission of Hepatitis C from an infected donor to a recipient who does not have Hepatitis C during organ transplantation.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Arm 1: Pre-emptive Treatment ArmExperimental Treatment1 Intervention
Single arm study were all recipients of HCV viremic organs will receive combination therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+