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Antiviral

HCV-Positive Organ Transplant Safety

Phase 3

Recruiting

Led By Jordan Feld, MD, MPH

Research Sponsored by Jordan Feld

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Age \<70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Approved for 10 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test if it's safe to transplant organs from donors with HCV to recipients who don't have HCV. The recipient will take medication before and after the transplant. If successful, this could provide a large number of organs for transplant.

Who is the study for?

This trial is for individuals under the age of 70 who need an organ transplant and are willing to receive organs from donors with Hepatitis C, using antiviral prophylaxis. It's not suitable for those outside this age range or those who may have conditions that could interfere with the study.

What is being tested?

The trial tests if it's safe to transplant organs from Hepatitis C positive donors into recipients without the virus by giving them antivirals (Glecaprevir/Pibrentasvir) and a cholesterol drug (Ezetimibe) that also blocks HCV entry into cells before and after surgery.

What are the potential side effects?

Potential side effects include reactions to Glecaprevir/Pibrentasvir such as headache, fatigue, nausea, and ezetimibe might cause stomach pain or diarrhea. The procedure itself carries risks associated with organ transplants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of HCV transmission [Safety]

Incidence of treatment-emergent adverse events [Safety and Tolerability]

Post-transplant Survival [Safety]

Secondary study objectives

Acute Cellular Rejection

HCV Seroconversion

Long-Term Organ Function for Heart Recipients

+4 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Non Randomized InterventionExperimental Treatment3 Interventions

Intervention description: recipients on the wait-list for lung, heart, kidney, and/or pancreas transplants will all receive antiviral treatment in the form of 8 total doses of oral tablets. Lung recipients will also receive donor lungs that are treated with normothermic EVLP (details of both described below). Drug: All recipients will receive glecaprevir (300mg)/pibrentasvir (120mg) supplied as three tablets per dose 6-12 hours prior to transplant, and for 7 days post-transplant. Other Names: Maviret. Patients will also receive ezetimibe (10mg), supplied as one tablet per dose to be taken at the same time as Maviret tablets (6-12 hours prior to transplant in addition to 7 daily doses post-transplant). Ex Vivo Lung Perfusion (EVLP): Normothermic EVLP is a method of donor lung preservation, assessment, treatment, and repair of injured organs. This method allows donor lungs to be treated for at least 12h under protective physiological conditions. Other names: Normothermic EVLP.

0 / 1Eligibility criteria met