Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 7 for:    Hepatitis C | Heart Transplant
Previous Study | Return to List | Next Study

Expanding the Pool in Orthotopic Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03222531
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Sciortino, University of Pittsburgh

Brief Summary:
This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Condition or disease Intervention/treatment Phase
Hepatitis C Heart Transplant Cardiac Transplant Drug: sofosbuvir/velpatasvir Phase 2

Detailed Description:

This is a prospective, single center, pilot, open-label study of transplantation of hearts of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a heart from HCVAb+/NAT- donors is ARM 1 or the transmission-triggered arm of the study. In this arm, the study will monitor transmission of HCV by measuring HCV RNA in heart transplant recipients. If HCV RNA is detected, indicating transmission of HCV, recipients will be treated with sofosbuvir/velpatasvir (Epclusa®) for 12 weeks. Virological response will be assessed at 4 weeks, end of treatment and 12 weeks after completion of therapy.

Recipients of a heart from HCVAb+/NAT+ donors will be in ARM 2 or the prophylaxis arm of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) on post-operative day 1 and will undergo close monitoring of HCV RNA for evidence of transmission as well as monitoring of adverse events from therapy.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Expanding the Pool in Orthotopic Heart Transplantation: The Use of Hepatitis C Positive Donor Hearts in Hepatitis C Negative Recipients
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: HCV seropositive non-viremic (HCV Ab+/NAT-) donor

HCV seropositive non-viremic (HCV Ab+/NAT-) donor hearts to HCV seronegative recipients.

Heart recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.

Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Intervention: Drug: sofosbuvir/velpatasvir

Drug: sofosbuvir/velpatasvir
Drug: sofobuvir/velpatasvir
Other Name: Epclusa

Experimental: HCV seropositive viremic (HCV Ab+/NAT+) donor

HCV seropositive viremic (HCV Ab+/NAT+) donor hearts to HCV seronegative recipients.

Starting post-operative day 1, heart recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Intervention: Drug: sofosbuvir/velpatasvir

Drug: sofosbuvir/velpatasvir
Drug: sofobuvir/velpatasvir
Other Name: Epclusa




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 5 years ]
    Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group

  2. HCV free at 1 year [ Time Frame: 1 year ]
    Proportion of participants in each experimental group who are free of HCV at 1 year following transplantation


Secondary Outcome Measures :
  1. Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients [ Time Frame: 5 years ]
  2. Incidence of allograft rejection [ Time Frame: 5 years ]
  3. Incidence of graft loss [ Time Frame: 5 years ]
  4. All-cause mortality [ Time Frame: 5 years ]
  5. Waitlist time after enrollment [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (recipients):

  • End stage heart failure
  • Age ≥ 18 and <71 years
  • Listed heart transplant at UPMC
  • Have panel reactive antibody level of <98%
  • No obvious contraindication to liver transplant
  • Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
  • Able to provide informed consent
  • Be willing to use a contraceptive method for a year after transplant

Inclusion criteria (donors):

  • HCV antibody positive
  • HCV NAT negative or positive
  • Acceptable cardiac function for donation

Exclusion criteria (recipients):

  • HIV positive
  • HCVAb or HCV RNA positive
  • Presence of behavioral risk factors for contracting HCV. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.
  • Hepatitis B surface antigen positive
  • History of liver cirrhosis
  • Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months
  • Waitlisted for a multi-organ transplant
  • Pregnant women
  • Known allergy to sofosbuvir/velpatasvir
  • Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
  • Ongoing therapy with amiodarone for atrial or ventricular arrhythmia Prescribed use of Amiodarone

Exclusion criteria (donors):

  • Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)
  • Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT) Known ongoing therapy for HCV

Information from the National Library of Medicine

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): NCT03222531


Contacts
Layout table for location contacts
Contact: Christopher Sciortino, MD 412-648-3202 sciortinocm@upmc.edu
Contact: Traci McGaha, RN 412-692-4828 mcgahatl4@upmc.edu

Locations
Layout table for location information
United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christopher Sciortino, MD    412-647-6636    sciortinocm@upmc.edu   
Principal Investigator: Christopher Sciortino         
Sponsors and Collaborators
University of Pittsburgh

Layout table for additonal information
Responsible Party: Christopher Sciortino, Assistant Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03222531     History of Changes
Other Study ID Numbers: PRO17020069
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents