Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant

Phase 4

Withdrawn

• Conditions: Cardiac Transplant Disorder; Hepatitis C
• Interventions: Drug: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin

• Registration Number: NCT03026023
• Lead Sponsor: Raymond T. Chung, MD

Brief Summary

This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.

Detailed Description

Phase 1 of this study will be a single case study with only one subject enrolled. Once safety has been demonstrated and HCV infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients.

Patients will be selected based on their diminished likelihood of receiving a heart from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's listing status (1A, 1B, 2) and clinical judgment, and the Seattle Heart Failure Model.

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-20
• Study Start: 2018-08-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Recipient is Age ≥ 18 years
• Serum ALT within normal limits with no history of liver disease
• Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Exclusion Criteria

• Sensitization (i.e. PRA >20%)
• Any liver disease in recipient
• Albumin < 3g/dl or platelet count < 75 x 103/mL
• Need for dual organ transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with grazoprevir + elbasvir +/- ribavirin	Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin	12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin

Primary Outcome Measures

Name	Time	Method
Undetectable HCV	12 Weeks post treatment	Negative HCV viral RNA at 12 weeks after the last dose of treatment.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation	Upto 16 Weeks	Safety and tolerability of grazoprevir and elbasvir in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.

Trial Locations

Locations (1)

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