NCT03383419

Brief Summary

This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
8mo left

Started Mar 2018

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2018Dec 2026

First Submitted

Initial submission to the registry

December 7, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 22, 2026

Status Verified

October 1, 2025

Enrollment Period

8.8 years

First QC Date

December 7, 2017

Last Update Submit

January 21, 2026

Conditions

Heart Failure

Keywords

Heart Failure, Heart Transplant

Outcome Measures

Primary Outcomes (1)

  • Sustained virologic response after 12 weeks of treatment

    To evaluate the number of patients with sustained virologic response (SVR) 12 weeks after discontinuation of therapy.

    12 weeks

Secondary Outcomes (1)

  • 1-year post-transplant survival

    1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Epclusa® will be started within 14 days of quantifiable viremia and continued for 12 weeks. Within 24 hours prior to first-dose of treatment, HCV genotype will be sent from transplant recipient.

Drug: Epclusa

Interventions

EpclusaDRUG

If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.

Treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and capable of providing written informed consent
  • Age ≥ 18 years
  • Listed for isolated orthotopic heart transplant
  • HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or fully-treated and cleared prior infection; in this case last anti-HCV antiviral dose must be ≥12 weeks ago and 2 negative titers ≥12 weeks after completion of the antiviral regimen)

You may not qualify if:

  • Listed for combined organ transplant
  • Any of the following liver disease states, including:
  • History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
  • Hepatitis B surface Ag positive(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant surface antigen) or detectable hepatitis B DNA,
  • Cirrhosis, as indicated by liver biopsy,
  • Portal hypertension as indicated by a hepatic venous pressure gradient \> 5 mm Hg and/or the presence of esophageal varices e.) ALT and AST \> 3x ULN unless adjudicated to be from a non-hepatic cardiac or skeletal muscle source,
  • History of prior solid organ transplant
  • Pregnant individuals
  • History of HIV infection
  • History of severe renal disease currently requiring dialysis. Chronic kidney disease with creatinine clearance \<30 ml/min/1.73m2 (by MDRD method) at screening or on last two consecutive measurements before acceptance of transplant organ offer
  • Patients who have undergone or who will undergo immune desensitization therapy
  • Prospective-positive cross-match or predicted positive cross-match
  • Patients unwilling to notify their sexual partner(s) of participation in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27705, United States

ACTIVE NOT RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

Related Publications (1)

  • Mozaffari E, Chandak A, Zhang Z, Liang S, Thrun M, Gottlieb RL, Kuritzkes DR, Sax PE, Wohl DA, Casciano R, Hodgkins P, Haubrich R. Remdesivir Treatment in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19): A Comparative Analysis of In-hospital All-cause Mortality in a Large Multicenter Observational Cohort. Clin Infect Dis. 2022 Aug 24;75(1):e450-e458. doi: 10.1093/cid/ciab875.

    PMID: 34596223DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Shelley A Hall, MD, FACC, FHFSA

    Baylor University Medical Center/ Baylor Scott & White Research Institute

    STUDY CHAIR

Central Study Contacts

Aayla Jamil, MBBS MPH

CONTACT

214-820-1675Aayla.Jamil@BSWHealth.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 26, 2017

Study Start

March 20, 2018

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 22, 2026

Record last verified: 2025-10

Locations

US(3)