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Antisense Oligonucleotide

Eplontersen for Transthyretin Amyloid Cardiomyopathy

Phase 3

Recruiting

Research Sponsored by Ionis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 36 months

Awards & highlights

Study Summary

This trial tests if a drug is safe & tolerable for people with a rare heart condition.

Who is the study for?

This trial is for adults with a heart condition called ATTR-CM who have completed a previous eplontersen study or were part of the ISIS 420915-CS101 study and judged suitable by the investigator. Participants must be willing to take vitamin A as required and not have any new or worsening conditions that could affect their participation.Check my eligibility

What is being tested?

The trial is testing the long-term safety of continued doses of a drug named Eplontersen in patients with Transthyretin-Mediated Amyloid Cardiomyopathy, which affects the heart. It aims to understand how well people tolerate this medication over an extended period.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to Eplontersen during their extended treatment to ensure its ongoing safety and tolerability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change From Baseline in ALT

Change From Baseline in AST

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

+6 more

Secondary outcome measures

Change From Baseline in 5 Level EuroQol - 5 Dimension (EQ-5D-5L)

Change From Baseline in 6-minute Walk Test (6MWT)

Change From Baseline in Biomarker: High Sensitivity Cardiac Troponin T (hs-cTnT)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: EplontersenExperimental Treatment1 Intervention

Eplontersen will be administered once every month by sub-cutaneous (SC) injection for up to 36 months or 6 months after eplontersen is approved and available in the site's country, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eplontersen

2020

Completed Phase 3

~200

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor

146 Previous Clinical Trials

13,882 Total Patients Enrolled

1 Trials studying Transthyretin Amyloid Cardiomyopathy

80 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy

AstraZenecaIndustry Sponsor

4,267 Previous Clinical Trials

288,605,581 Total Patients Enrolled

1 Trials studying Transthyretin Amyloid Cardiomyopathy

60 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy

Media Library

Transthyretin Amyloid Cardiomyopathy Research Study Groups: Eplontersen

Frequently Asked Questions

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

How many individuals are taking part in this scientific experiment?

"Affirmative, the information hosted on clinicaltrials.gov attests to this investigation's active recruitment of participants. It was inaugurated on November 30th 2022 and most recently modified on December 19th 2022; 1400 individuals are expected be admitted across one centre."

Answered by AI

Has Eplontersen received authorization from the Food and Drug Administration?

"We have rated eplontersen's safety at 3 due to the presence of Phase 3 clinical data that has demonstrated its efficacy and repeated confirmation of its security."

Answered by AI

Are participants currently being accepted for this experiment?

"Affirmative. The clinicaltrials.gov website states that this medical experiment is actively looking for patients and has been since November 30th 2022. Most recently, the trial was updated on December 19th of the same year and requires 1400 participants from 1 single site to take part in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

2022. "An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05667493.

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