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Antiviral

HCV-Positive Organ Transplant Safety

Q: What conditions does Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet commonly treat?

Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet is most often used as a treatment for <a href="https://www.withpower.com/clinical-trials/hepatitis-c">hepatitis c</a>. However, it has also been found to be effective in managing <a href="https://www.withpower.com/clinical-trials/diet">diet</a>, mixed hyperlipidemia, and previous treatment with ns3/4a protease inhibitor.

Q: Are there other examples of research involving Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet?

As of right now, there are 26 different clinical trials ongoing for Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet. 4 of these trials are in Phase 3. The majority of these trials are being conducted in Baltimore, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>, but there are 139 total locations running these studies.

Q: What are the risks associated with taking Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet?

Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet has been studied in Phase 3 clinical trials. This means that while there is some evidence of efficacy, there is also extensive safety data. Our team rates it a 3 on a 1-3 scale.

Q: Are there other ongoing studies like this one?

Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet has been researched since 2014. The first clinical trial was sponsored by IlDong Pharmaceutical Co Ltd and concluded in the same year. The Phase 3 drug approval followed the initial 400-patient study. Presently, there are 26 active studies involving this medication being conducted in 73 cities across 15 nations.

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of HCV transmission [Safety]

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

Post-transplant Survival [Safety]

Secondary outcome measures

Acute Cellular Rejection

HCV Seroconversion

Long-Term Organ Function for Heart Recipients

+4 more

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

Find a Location

Who is running the clinical trial?

Jordan FeldLead Sponsor

1 Previous Clinical Trials

2,920 Total Patients Enrolled

1 Trials studying Hepatitis C

2,920 Patients Enrolled for Hepatitis C

University Health Network, TorontoOTHER

1,473 Previous Clinical Trials

484,965 Total Patients Enrolled

15 Trials studying Hepatitis C

1,134 Patients Enrolled for Hepatitis C

Jordan Feld, MD, MPHPrincipal InvestigatorUniversity Health Network Toronto General Hospital

Media Library

Glecaprevir/Pibrentasvir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04017338 — Phase 3

Hepatitis C Research Study Groups: Non Randomized Intervention

Hepatitis C Clinical Trial 2023: Glecaprevir/Pibrentasvir Highlights & Side Effects. Trial Name: NCT04017338 — Phase 3

Glecaprevir/Pibrentasvir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04017338 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions does Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet commonly treat?

"Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet is most often used as a treatment for hepatitis c. However, it has also been found to be effective in managing diet, mixed hyperlipidemia, and previous treatment with ns3/4a protease inhibitor."

Answered by AI

Are there other examples of research involving Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet?

"As of right now, there are 26 different clinical trials ongoing for Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet. 4 of these trials are in Phase 3. The majority of these trials are being conducted in Baltimore, Maryland, but there are 139 total locations running these studies."

Answered by AI

What are the risks associated with taking Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet?

"Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet has been studied in Phase 3 clinical trials. This means that while there is some evidence of efficacy, there is also extensive safety data. Our team rates it a 3 on a 1-3 scale."

Answered by AI

Are there other ongoing studies like this one?

"Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet has been researched since 2014. The first clinical trial was sponsored by IlDong Pharmaceutical Co Ltd and concluded in the same year. The Phase 3 drug approval followed the initial 400-patient study. Presently, there are 26 active studies involving this medication being conducted in 73 cities across 15 nations."

Answered by AI