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

NCT04515797 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2020P002523
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure; Hepatitis C; Kidney Disease, Chronic

Keywords

Kidney Transplant; Kidney Failure; HCV; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Undetectable Blood HCV RNA Level

  Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P

  12 weeks post last dose of treatment with G/P

Secondary Outcomes (4)

• Adverse Events

  1 Year Study Period

• HCV RNA Viral Load

  Measured at Week 2 and Week 4 of Treatment;

• Allograft Function

  1 Year Study Period

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

  1 Year Study Period

Study Arms (1)

Treatment with Direct Acting Antiviral for HCV

EXPERIMENTAL

4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant

Drug: Glecaprevir and Pibrentasvir

Interventions

Glecaprevir and Pibrentasvir DRUG

4 weeks of treatment starting within 24 hrs of kidney transplant

Also known as: Direct Acting Antiviral HCV Treatment, Mavyret

Treatment with Direct Acting Antiviral for HCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
• Able to sign informed consent
• Detectable HCV NAT test
• KDPI score is less than ≤ 0.850
• Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

You may not qualify if:

• Pregnant or nursing (lactating) women
• HBV positivity (Ag or DNA)
• Any contra-indication to kidney transplantation per MGH transplant center protocol
• Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
• Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert
• Confirmed HIV
• Confirmed HBV positive (surface antigen or HBV DNA positive)
• Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Hepatitis C; Renal Insufficiency, Chronic

Interventions

glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was closed prior to completion and prior to achieving the target of 40 participants enrolled due to the expiration of the donated investigational product (Glecaprevir / Pibrentasvir). The final study enrollment of 2 participants provides insufficient data to support analysis of all defined secondary outcomes.

Results Point of Contact

• Title: Dr. Raymond Chung
• Organization: Massachusetts General Hospital

Chung.Raymond@mgh.harvard.edu

6177247562

Study Officials

• Nahel Elias, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Director, Kidney Transplant

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: May 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Locations

US (1)