Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant
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|ClinicalTrials.gov Identifier: NCT03026023|
Recruitment Status : Withdrawn (moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved)
First Posted : January 20, 2017
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Transplant Disorder Hepatitis C||Drug: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant|
|Estimated Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Treatment with grazoprevir + elbasvir +/- ribavirin
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
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.
Other Name: Zepatier
- Undetectable HCV [ Time Frame: 12 Weeks post treatment ]Negative HCV viral RNA at 12 weeks after the last dose of treatment.
- 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026023
|United States, Massachusetts|
|Masschusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Raymond T Chung, MD||Massachusetts General Hospital|