NCT03781726

Multi-center Study to Transplant Hepatitis-C Infected Kidneys

A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Raymond Chung · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Detailed description

The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Conditions

• Renal Failure Chronic
• Hepatitis C

Interventions

Type	Name	Description
DRUG	glecaprevir/pibrentasvir treatment	combination treatment with glecaprevir and pibrentasvir fixed dose tablet.

Timeline

• Start date: 2019-04-10
• Primary completion: 2020-03-20
• Completion: 2021-12-31
• First posted: 2018-12-20
• Last updated: 2022-01-26
• Results posted: 2021-05-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study