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

NCT03026023 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2017P000074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Transplant Disorder; Hepatitis C

Keywords

Heart Transplant; Cardiac Transplant; Hepatitis C; Zepatier

Outcome Measures

Primary Outcomes (1)

• Undetectable HCV

  Negative HCV viral RNA at 12 weeks after the last dose of treatment.

  12 Weeks post treatment

Secondary Outcomes (1)

• 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

Study Arms (1)

Treatment with grazoprevir + elbasvir +/- ribavirin

EXPERIMENTAL

12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin

Drug: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin

Interventions

Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin DRUG

HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.

Also known as: Zepatier

Treatment with grazoprevir + elbasvir +/- ribavirin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raymond T. Chung, MD: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Masschusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

grazoprevir; elbasvir; elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Raymond T Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hepatology

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 20, 2017
• Study Start: August 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)