Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

NCT02945150 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2016P002051Merck MISP 54841
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Conditions

Renal Failure

Keywords

hemodialysis; peritoneal dialysis; renal failure; kidney transplant

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Undetectable HCV RNA at SVR12

  Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV.

  12 weeks post-treatment (24 weeks post-transplant)

Secondary Outcomes (1)

• Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365

  1 year post transplant

Study Arms (1)

Elbasvir/grazoprevir for HCV+ kidney transplant recipients

EXPERIMENTAL

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Drug: elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)

Interventions

elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) DRUG

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Also known as: Zepatier

Elbasvir/grazoprevir for HCV+ kidney transplant recipients

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
• No available living kidney donor
• Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
• On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate \<15mL/min/1.73m2 at the time of screening
• Weight ≥ 50kg
• Serum alanine transaminase (ALT) within normal limits

You may not qualify if:

• AB blood type
• Body mass index (BMI \> 35
• History of liver disease
• Pregnant or nursing (lactating) women
• Cardiomyopathy (LV ejection fraction \< 50%)
• Positive crossmatch or positive donor specific antibodies
• Human immunodeficiency virus (HIV) positive
• Hepatitis C virus (HCV) RNA positive
• Hepatitis B virus (HBV) surface antigen positive
• Any contraindication to kidney transplant per MGH center protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Kucirka LM, Singer AL, Ros RL, Montgomery RA, Dagher NN, Segev DL. Underutilization of hepatitis C-positive kidneys for hepatitis C-positive recipients. Am J Transplant. 2010 May;10(5):1238-46. doi: 10.1111/j.1600-6143.2010.03091.x. Epub 2010 Mar 26.

  PMID: 20353475 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Interventions

elbasvir; grazoprevir; elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

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

Chung.Raymond@mgh.harvard.edu

617-724-7562

Study Officials

• Raymond Chung, MD

  Massachusetts General Hospital (Partners Healthcare)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hepatology, Massachusetts General Hospital

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 26, 2016
• Study Start: February 1, 2017
• Primary Completion: August 20, 2019
• Study Completion: March 5, 2020
• Last Updated: June 9, 2020
• Results First Posted: February 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Protocol will be shared for up to 1 year after the final patient has dosed.
• Access Criteria: Protocol will only be shared with Institutional Review Board (IRB) approved study staff and PI approved collaborators.

Locations

US (1)