NCT03801707

Utilization of Hepatitis C Positive Kidneys in Negative Recipients

An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

Detailed description

This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using treatment with pan-genotypic direct acting antiviral therapies (DAAS) for treatment of post-transplant HCV transmission

Conditions

• Kidney Transplant
• Hepatitis C
• HCV

Interventions

Type	Name	Description
DRUG	Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]	fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
DRUG	Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]	Three tablets once a day for 12 weeks for treatment of hepatitis C

Timeline

• Start date: 2019-03-22
• Primary completion: 2021-04-28
• Completion: 2021-04-30
• First posted: 2019-01-11
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study