QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

Phase 4

Terminated

• Conditions: Hepatitis C; Kidney Failure; Kidney Disease, Chronic
• Interventions: Drug: Glecaprevir and Pibrentasvir

• Registration Number: NCT04515797
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Detailed Description

The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-17
• Study Start: 2021-05-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Results First Submitted: 2024-07-12
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Results First Posted: 2024-12-03
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Direct Acting Antiviral for HCV	Glecaprevir and Pibrentasvir	4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant

Primary Outcome Measures

Name	Time	Method
Number of Participants With Undetectable Blood HCV RNA Level	12 weeks post last dose of treatment with G/P	Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 Year Study Period	Serious and non-serious adverse events attributed to study drug and/or HCV-viremia
HCV RNA Viral Load	Measured at Week 2 and Week 4 of Treatment;	Assessment of HCV RNA viral load at on-treatment visits, measured at both week 2 and week 4 on treatment. The viral loads measured at Week 2 and 4 are averaged together and reported in copies per mL
Allograft Function	1 Year Study Period	Post-transplant allograft function measured by mean eGFR over study period
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed Graft Function, ALT Elevation	1 Year Study Period	The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations \> 5x ULN related to study treatment with glecaprevir/Pibrentasvir

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States