Study on the Safety of Acoramidis in Patients with Transthyretin Amyloid Cardiomyopathy Who Completed a Previous Trial

3 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Transthyretin Amyloid Cardiomyopathy (ATTR-CM). This is a heart disease where abnormal proteins build up in the heart, affecting its function. The study involves a treatment called Acoramidis (AG10), which is taken in tablet form. The purpose of the study is to monitor the safety and how well patients tolerate this medication.

Participants in this study are those who have already completed a previous trial involving the same medication. During the study, participants will continue to take Acoramidis and will be regularly monitored for any side effects or changes in their health. This includes checking for any serious health events, changes in physical exams, vital signs, and heart tests like electrocardiograms (ECG). The study will also look at overall health outcomes, such as any changes in walking distance and heart-related hospital visits.

The study aims to provide valuable information on the long-term safety of Acoramidis for people with ATTR-CM. It will help understand how the medication affects the heart and overall health over time. Participants will be closely observed to ensure their safety and to gather data that could benefit future patients with this condition.

1 joining the study

Participation begins after completing 30 months of the previous study, AG10-301, including all assessments and procedures.

A written informed consent form must be understood and signed before starting any study procedures.

2 medication administration

The medication used in this study is acoramidis (AG10), administered in the form of a tablet.

The route of administration is oral use.

3 safety and monitoring

The main objective is to assess the safety and tolerability of acoramidis in participants with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM).

Safety parameters include monitoring for serious adverse events, adverse events leading to treatment discontinuation, and any abnormal findings in physical examinations, vital signs, and electrocardiogram (ECG) parameters.

4 secondary assessments

Secondary assessments include monitoring all-cause mortality and cardiovascular (CV) mortality.

Changes from baseline in the distance walked during the 6-minute walk test (6MWT) and the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) are evaluated.

CV-related hospitalizations and changes in transthyretin (TTR) levels are also assessed.

5 study duration

The estimated end date for the study is May 9, 2028.

The study began recruiting participants on October 1, 2021.

Who Can Join the Study?

Must have completed 30 months of the study treatment in a previous related study, including all required visits and procedures.
Must be able to understand and sign a written consent form before starting any study procedures.
Female participants who can have children and are sexually active with men must agree to use a highly effective method of birth control from the time they join the study until 30 days after their last dose of the study medication. If using birth control pills, they must also use another method of birth control. A double-barrier method (like using a condom with a diaphragm) is acceptable, even though it’s not considered highly effective.
Male participants who are sexually active with women who can have children and have not had a vasectomy must agree to use a double-barrier method of birth control.

Who Cannot Join the Study?

Patients who do not have symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) cannot participate. This is a condition where a protein called transthyretin builds up in the heart, causing symptoms.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who do not meet the gender criteria cannot participate. Both males and females are eligible for this study.
Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Fondazione Toscana Gabriele Monasterio	Pisa	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Alexandra Hospital	Athens	Greece
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Son Llatzer	Palma	Spain
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Ziekenhuis Oost Limburg	Genk	Belgium
Azienda USL Toscana Sud Est	Arezzo	Italy
Iyzltrljf Fxy Cgzeuixu Aqh Etryynqakgfa Mjondjlj	Prague	Czechia
Ueapjfnimzve Mughjib Ctdcpsh Ghqvpqfno	Groningen	The Netherlands
Aidkas Umofpughgs Hwlfmzxk	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2021
Czechia	Not recruiting	01.10.2021
Denmark	Not recruiting	01.10.2021
Greece	Not recruiting	01.10.2021
Ireland	Not recruiting	01.10.2021
Italy	Not recruiting	01.10.2021
Portugal	Not recruiting	01.10.2021
Spain	Not recruiting	01.10.2021
The Netherlands	Not recruiting	01.10.2021

Trial locations

Acoramidis (AG10) is a medication being studied for its safety and tolerability in people with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM). This condition affects the heart, and the medication aims to help manage the symptoms associated with it. Participants in this study have previously completed a Phase 3 trial, and this extension study continues to monitor the effects of Acoramidis on their condition.

Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM) – This is a condition where abnormal protein deposits, known as amyloid, accumulate in the heart tissue. These deposits are made of transthyretin, a protein that normally transports thyroid hormone and vitamin A in the blood. Over time, the buildup of amyloid can cause the heart walls to become stiff, leading to difficulties in the heart’s ability to pump blood effectively. As the disease progresses, individuals may experience symptoms such as fatigue, shortness of breath, and swelling in the legs. The condition is considered rare and can significantly impact the quality of life.

Trial ID:

2024-515092-36-00

Protocol code:

AG10-304

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Safety of Acoramidis in Patients with Transthyretin Amyloid Cardiomyopathy Who Completed a Previous Trial

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?