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

Hepatitis C Clinical Trial

— QUICK-CURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515797
• Other study ID #: 2020P002523
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Recipient)

1. Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy)

2. Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method

3. No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team

4. Able to sign informed consent

Inclusion Criteria (Deceased Donor)

1. Detectable HCV NAT test

2. KDPI score is less than = 0.850

3. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Exclusion Criteria (Recipient)

1. Pregnant or nursing (lactating) women

2. HBV positivity (Ag or DNA)

3. Any contra-indication to kidney transplantation per MGH transplant center protocol

4. Any signs or symptoms of clinically significant chronic liver disease per transplant center physician

5. Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert

Exclusion Criteria (Deceased Donor)

1. Confirmed HIV

2. Confirmed HBV positive (surface antigen or HBV DNA positive)

3. Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Glecaprevir and Pibrentasvir
4 weeks of treatment starting within 24 hrs of kidney transplant

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	Sustained virologic response 12 weeks after completing G/P	12 weeks post-treatment (16 weeks post-transplant)
Secondary	Adverse Events	Serious and non-serious adverse events attributed to study drug and/or HCV-viremia	1 Year Study Period
Secondary	HCV RNA Viral Load	Assessment of HCV RNA viral load at on-treatment visits	Weeks 2 and 4 of Treatment
Secondary	Allograft Function	Post-transplant allograft function measured by mean eGFR over study period	1 Year Study Period
Secondary	Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed graft function, ALT elevation	The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN	1 Year Study Period