NCT03093740

Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Open label single 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 direct acting antivirals for 12-16 weeks after kidney transplantation prevents 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	Zepatier	Based on negative viral resistance testing of the donor treatment will be Zepatier
DRUG	Zepatier plus Sofosbuvir	Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-12-31
• Completion: 2021-01-31
• First posted: 2017-03-28
• Last updated: 2018-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study