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TEGSEDI Safety Profile for Amyloid Neuropathies

Phase 4

Recruiting

Research Sponsored by Akcea Therapeutics

Eligibility Criteria Checklist

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

Must have

Males: Abstinent or if engaged in sexual relations with a female of childbearing potential, patient is utilizing an acceptable contraceptive method from the time of signing the ICF until 13 weeks after the last dose of TEGSEDI administration

Are about to initiate or have recently initiated treatment with TEGSEDI and have not received more than 9 doses in total

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year minimum to 2 years maximum

Awards & highlights

Study Summary

This trial is looking at how well TEGSEDI works in people with hATTR-PN and what side effects there are.

Who is the study for?

This trial is for adults over 18 with hATTR-PN, a type of amyloidosis affecting nerves. Participants must be starting or have recently started TEGSEDI treatment and taken fewer than 9 doses. They should not be pregnant or breastfeeding and must use contraception if they can have children. Access to past medical records is required.Check my eligibility

What is being tested?

The study aims to observe any adverse events that occur within one day after taking TEGSEDI in patients with hATTR-PN by monitoring vital signs, preventive measures, treatments needed, risk factors, and outcomes through blood tests for immune response and inflammation markers.See study design

What are the potential side effects?

While the trial focuses on characterizing side effects occurring within a day of taking TEGSEDI, potential side effects may include reactions at the injection site, changes in vital signs like blood pressure or heart rate, allergic responses, or other immediate post-dose symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I am a male using birth control or abstaining from sex if my partner can have children.

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I am starting or have recently started TEGSEDI treatment and have had less than 10 doses.

Select...

I am over 18, diagnosed with hATTR-PN, and prescribed TEGSEDI.

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I am an adult in Canada with early-stage hATTR PN and prescribed TEGSEDI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year minimum to 2 years maximum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year minimum to 2 years maximum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year minimum to 2 years maximum for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To characterize AEs occurring within one day of TEGSEDI administration to adult patients with hATTR-PN.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Group 1Experimental Treatment3 Interventions

TEGSEDI

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Akcea TherapeuticsLead Sponsor

23 Previous Clinical Trials

1,962 Total Patients Enrolled

Media Library

Group 1 Clinical Trial Eligibility Overview. Trial Name: NCT04306510 — Phase 4

Transthyretin Amyloidosis with Polyneuropathy Research Study Groups: Group 1

Transthyretin Amyloidosis with Polyneuropathy Clinical Trial 2023: Group 1 Highlights & Side Effects. Trial Name: NCT04306510 — Phase 4

Group 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04306510 — Phase 4

Frequently Asked Questions

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

How many participants are receiving this experimental treatment?

"Affirmative. The clinical trial listing on clinicaltrials.gov reveals that they are actively recruiting participants, with the first posting having been made on January 21st 2021 and most recently updated in December 16th 2021. In total, 75 people need to be recruited from 4 distinct sites."

Answered by AI

Has this remedy attained governmental authorization?

"This therapeutic solution is approved by the FDA, so it earned a score of 3 on our safety assessment."

Answered by AI

Are there opportunities for enrolment in this clinical trial?

"According to the clinicaltrials.gov website, this medical trial is currently admitting participants. The study was first listed on January 21st 2021 and has been updated as recently as December 16th 2021."

Answered by AI

Are there any locations within the state where this clinical experiment is being held?

"The 4 clinical trial sites that are running this research project are located in Rosedale, Portland, Toronto and other nearby regions. To reduce the need for travelling distance, it's best to select a site near you if you choose to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Patients With hATTR-PN

2021. "A Clinical Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Patients With hATTR-PN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04306510.

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