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Transthyretin Stabilizer
AG10 for Cardiomyopathy
Phase 2
Waitlist Available
Research Sponsored by Eidos Therapeutics, a BridgeBio company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Females who are pregnant or breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months or study completion by recommendation from safety monitoring committee
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the long-term effects of AG10 on people with heart failure.
Who is the study for?
This trial is for patients with cardiomyopathy who have completed a prior AG10 study. Participants must be stable enough to follow the treatment plan and agree to use contraception if necessary. Those at risk of heart transplant, on certain other treatments, or with significant health risks are excluded.
What is being tested?
The study tests the long-term safety and effects of AG10 in individuals with cardiomyopathy while they continue their usual heart failure therapy. It's an open-label trial, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions related to heart function or interactions with existing medications. As it's a safety study, monitoring for any adverse effects will be a key part of the trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding, or I agree to stop breastfeeding to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months or study completion by recommendation from safety monitoring committee
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months or study completion by recommendation from safety monitoring committee
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of long-term safety and tolerability: Incidence of each treatment-emergent adverse events
Secondary study objectives
AG10 Pharmacodynamic Assessments of TTR stabilization by Fluorescent Polarization Exclusion Assay
AG10 Pharmacodynamic Assessments of TTR stabilization by Western Blot
AG10 Pharmacodynamic Assessments: prealbumin
+1 moreSide effects data
From 2018 Phase 2 trial • 49 Patients • NCT0345813013%
Oedema Peripheral
13%
Venous Pressure Jugular Increased
13%
Diarrhoea
6%
Dyspnoea
6%
Groin Pain
6%
Muscle Spasms
6%
Atrial Fibrillation
6%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
AG10 400mg
AG10 800mg
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-LabelExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG10
2018
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Eidos Therapeutics, a BridgeBio companyLead Sponsor
11 Previous Clinical Trials
2,362 Total Patients Enrolled
2 Trials studying Amyloid Cardiomyopathy
1,214 Patients Enrolled for Amyloid Cardiomyopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood tests show dangerous abnormalities that could be risky for you.You are allergic to the study drug AG10 or any of its ingredients.You might need a heart transplant or a mechanical heart device in the next year.I am not currently taking specific medications like diflunisal or green tea extracts for ATTR.I am not pregnant or breastfeeding, or I agree to stop breastfeeding to participate.I understand the study and have given my consent to participate.I don't have any health issues that could make the trial unsafe for me.I agree to use effective birth control if there's any chance of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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