Ex Vivo Lung Perfusion for Hepatitis C

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University Health Network Toronto General Hospital, Toronto, Canada
Hepatitis C+8 More
Ex Vivo Lung Perfusion - Device
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug regimen can prevent HCV transmission from a donor to a recipient.

See full description

Eligible Conditions

  • Hepatitis C
  • Lung Transplant Infection
  • Kidney Transplant Infection
  • Heart Transplant Infection
  • Kidney Pancreas Infection

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Ex Vivo Lung Perfusion will improve 3 primary outcomes and 7 secondary outcomes in patients with Hepatitis C. Measurement will happen over the course of 30 days.

1 year
Acute Cellular Rejection
HCV Seroconversion
Long-Term Organ Function for Heart Recipients
Long-Term Organ Function for Kidney Recipients
Long-Term Organ Function for Pancreas Recipients
Long-Term Organ Function using Exercise Tolerance for Lung Recipients
Long-Term Organ Function using Spirometry for Lung Recipients
30 days
Incidence of treatment-emergent adverse events [Safety and Tolerability]
6 months
Incidence of HCV transmission [Safety]
Post-transplant Survival [Safety]

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Non Randomized Intervention
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. Ex Vivo Lung Perfusion is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Non Randomized InterventionIntervention 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

University Health Network Toronto General Hospital - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age <70

Patient Q&A Section

How many people get infections a year in the United States?

"A survey of infectious disease prevalence in an American city found a peak monthly prevalence of viral infections during the spring, winter, and early spring. There was peak prevalence of bacterial infections during the late winter and early spring. A similar survey of influenza prevalence found a peak in midwinter. These patterns may be due to variations in the frequency with which different infectious strains are detected." - Anonymous Online Contributor

Unverified Answer

What causes infections?

"A combination of environmental (including diet and lifestyle), genetic, and incidental (through vaccinations or infection) causes cause 50-70% of new infections and illnesses. Understanding how environmental circumstances, genetic and incidental mechanisms work together to cause infections and diseases is important to treating and preventing illnesses.\n" - Anonymous Online Contributor

Unverified Answer

Can infections be cured?

"Bacterial and viral infections are extremely difficult to treat because the body's immune system and the bacteria, viruses, and fungus are all involved with the immune system. A cure for an infection is a very rare event. The body's most powerful defense system is the immune system, which must work at proper levels not to overreact and destroy host tissues. A cure for infections is not likely. Infection treatments are typically aimed towards one type of microbial infection and typically do not target more than one type of pathogen at a time, with the goal being to eliminate the pathogen causing the infection." - Anonymous Online Contributor

Unverified Answer

What is infections?

"Infections are defined as illnesses that result from the presence of an infectious particle or substance in the body. Infections are generally caused by viruses or bacteria and have an infectious source that is typically a person or animal. These infections can affect any part of the body. All infections contain a virus or a bacterium.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for infections?

"The treatments for infections vary with the type of infection, the type of organism, and the treatment for each type of infection. Treatment can be divided into three categories: specific types of antibiotics tailored to the type of infection, antibiotics that are broad-spectrum, and medications that modulate the immunologic response. Understanding the treatment options and the type of infection or organism will help guide in the treatment of the infected individuals." - Anonymous Online Contributor

Unverified Answer

What are the signs of infections?

"All ages can be affected by infections, especially those that are highly contagious. Allergic, autoimmune and inflammatory disorders can also play a role in the development of infections as well." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets infections?

"The typical age for infection and illness in a group in which infection has a moderate incidence is 12 years old. This is significantly older than the age at which infection, as well as illness, was thought to occur in previous studies. Results from a recent paper suggest that an infection-focused approach to health promotion and early detection may be more effective. They also suggest that efforts to educate parents about vaccination, which can prevent infection, may be warranted." - Anonymous Online Contributor

Unverified Answer

How does ex vivo lung perfusion work?

"Ex vivo lung perfusion can be performed safely and effectively in mechanically ventilated children with [severe] chronic lung disease leading to [death] to allow effective treatment of fatal infection with MDR pathogens. More children would benefit from ex vivo lung perfusion if it had become established as the new treatment for this type of patient." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ex vivo lung perfusion for therapeutic use?

"The study found that the ex vivo lung perfusion model was effective in inducing transient lung damage which resulted in the rapid release of inflammatory mediators, the recruitment of immune cells, and the improvement of pulmonary inflammation, including edema and diffuse alveolar injury. Recent findings indicate that therapeutic use and optimization of this technology may be feasible in clinical treatment of ALI." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ex vivo lung perfusion?

"Withholding the most recent clinical trials, the majority of trials (60%) have been published in high impact journals and are likely to be of high relevance and usefulness. However, there are gaps and discrepancies in the number of registered trials and the publication rate of clinical trials. The quality of reporting and publishing may be improved by implementing the CONSORT and PRISMA guidelines." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating infections?

"The most common medications people get when they need medications are beta blockers, blood thinner drugs, and nonsteroid anti-inflammatories. Infections need to be treated by a physician.\n" - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for infections?

"Clinical trials may increase patient education, lead to better and much needed understanding of how infections operate, and help researchers develop and test treatment and control techniques that may offer new methods to treat infections with fewer side effects." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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