Epclusa for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Heart Failure+1 More
Epclusa - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether it is safe and effective to transplant hearts from donors with HCV into recipients who do not have HCV, and who are treated with the drugs sofosbuvir and velpatasvir.

Eligible Conditions
  • Heart Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
1-year post-transplant survival
12 weeks
Sustained virologic response after 12 weeks of treatment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pts With Hep C Virus Infection-Related Cryoglobulinemia
40%Increased fatigue
30%nausea and abdominal pain
20%Urinary frequency and/or dysuria
10%Herpes Zoster
This histogram enumerates side effects from a completed 2019 Phase 2 & 3 trial (NCT02825212) in the Pts With Hep C Virus Infection-Related Cryoglobulinemia ARM group. Side effects include: Increased fatigue with 40%, nausea and abdominal pain with 30%, Urinary frequency and/or dysuria with 20%, Herpes Zoster with 10%.

Trial Design

1 Treatment Group

Treatment
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Epclusa · No Placebo Group · Phase 2

Treatment
Drug
Experimental Group · 1 Intervention: Epclusa · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Velpatasvir
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
188 Previous Clinical Trials
186,203 Total Patients Enrolled
6 Trials studying Heart Failure
2,038 Patients Enrolled for Heart Failure
Shelley Hall, MD, FACC, FHFSAStudy ChairBaylor Health Care System
1 Previous Clinical Trials
50 Total Patients Enrolled
Shelley A Hall, MD, FACC, FHFSAStudy ChairBaylor University Medical Center/ Baylor Scott & White Research Institute

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Baylor University Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. Baylor University Medical Center: < 48 hours
Typically responds via
Email100.0%
Average response time
  • < 2 Days