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Eplontersen for Cardiomyopathy

Phase 3

Waitlist Available

Research Sponsored by Ionis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New York Heart Association (NYHA) class I-III

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 140

Awards & highlights

Study Summary

This trial is testing a new drug compared to placebo (a "sugar pill" with no medicine) to see if it can help people with a certain heart condition.

Who is the study for?

This trial is for adults with ATTR-CM, a type of heart disease caused by amyloid deposits. Participants must have certain heart measurements and confirmed amyloid deposits but can't be on specific heart medications, have had recent major cardiovascular events or procedures, or expect to need a heart transplant or assist device within a year.Check my eligibility

What is being tested?

The study tests Eplontersen's effectiveness against a placebo in patients with ATTR-CM who are also receiving standard care. The goal is to see if Eplontersen improves the condition more than an inactive substance.See study design

What are the potential side effects?

While not specified here, side effects may include reactions at the injection site, potential liver issues (as it's common with similar drugs), fatigue, nausea, and possible blood-related problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart condition allows me to perform daily activities with minimal to moderate difficulty.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 140

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 140

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 140 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Outcome of Cardiovascular (CV) Mortality and Recurrent CV Clinical Events up to Week 140

Secondary outcome measures

All-Cause Mortality up to Week 140

CV Clinical Events up to Week 140

CV Mortality up to Week 140

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EplontersenExperimental Treatment1 Intervention

Eplontersen by subcutaneous injection once every 4 weeks

Group II: PlaceboPlacebo Group1 Intervention

Eplontersen-matching placebo by subcutaneous injection once every 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eplontersen

2020

Completed Phase 3

~200

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor

146 Previous Clinical Trials

13,844 Total Patients Enrolled

1 Trials studying Transthyretin Amyloid Cardiomyopathy

80 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy

Media Library

AKCEA-TTR-LRx Clinical Trial Eligibility Overview. Trial Name: NCT04136171 — Phase 3

Transthyretin Amyloid Cardiomyopathy Research Study Groups: Eplontersen, Placebo

Transthyretin Amyloid Cardiomyopathy Clinical Trial 2023: AKCEA-TTR-LRx Highlights & Side Effects. Trial Name: NCT04136171 — Phase 3

AKCEA-TTR-LRx 2023 Treatment Timeline for Medical Study. Trial Name: NCT04136171 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patients are eligible for this research program?

"Amyloidosis patients, aged 18 to 90, are encouraged to enroll in this study. In order to be eligible, in addition to the amyloidosis diagnosis, patients must also have either Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99m Tc-hydrox"

Answered by AI

If a patient meets the qualifications, can they sign up for this research project?

"That is correct, the information available on clinicaltrials.gov does show that this study is still recruiting. This particular trial was first posted on March 13th, 2020 and was updated as recently as October 31st, 2020. The study is looking for a total of 1400 patients from 60 different centres."

Answered by AI

Will people experience any adverse effects from taking AKCEA-TTR-LRx?

"There is some clinical evidence to support the efficacy of AKCEA-TTR-LRx, and it has received multiple rounds of safety testing, so it is considered a safe medication."

Answered by AI

Are elderly patients being included in this research project?

"The age limit for patients looking to enroll in this study is 18 years old. However, there is no upper age limit, with the study welcoming patients that are less than 90 years old."

Answered by AI

Are there similar drugs to AKCEA-TTR-LRx that have been put through clinical trials?

"This novel medication was first studied in 2020 at Azienda Ospedaliera Universitaria Policlinico Gaetano Martino. Since its inception, there have been 18,266 completed trials. Presently, there are 3 active trials, a few of which are being conducted in London, Ontario."

Answered by AI

Is this study conducted in more than one place?

"There are 60 active sites for this trial, which are located in major metropolitan areas such as London, Calgary and Montréal. Additionally, there are 60 other locations. If possible, it is best to enroll at a site close to your home to limit travel."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

2020. "CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04136171.

All > Cardiomyopathy > Amyloidosis