NCT04515797: QUICK-CURE

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

Terminated Phase 4 Results posted Last updated 3 December 2024

What this trial tests

Phase 4 trial testing Glecaprevir and Pibrentasvir in Kidney Failure in 2 participants. Terminated before completion.

Timeline

1 May 2021

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	1 May 2021
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Glecaprevir and Pibrentasvir — full drug profile →

Conditions studied

• Kidney Failure — all drugs for Kidney Failure →
• Hepatitis C — all drugs for Hepatitis C →
• Kidney Disease, Chronic — all drugs for Kidney Disease, Chronic →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Kidney Failure or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Undetectable Blood HCV RNA Level Primary · 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

Group	Value	95% CI
Treatment With Direct Acting Antiviral for HCV	2

Adverse Events Secondary · 1 Year Study Period

Serious and non-serious adverse events attributed to study drug and/or HCV-viremia

Group	Value	95% CI
Treatment With Direct Acting Antiviral for HCV	0

HCV RNA Viral Load Secondary · 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

Group	Value	95% CI
Treatment With Direct Acting Antiviral for HCV	0	0 – 0

Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed Graft Function, ALT Elevation Secondary · 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

Group	Value	95% CI
Treatment With Direct Acting Antiviral for HCV	0	0 – 0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.