A Phase 3 Global Double-Blind Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Transthyretin Amyloid Cardiomyopathy
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Age: Between 18 years - 90 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants able to provide written informed consent
- Participants who are not pregnant or breastfeeding
- Participants must agree to use acceptable contraceptives as per the protocol
- Those who are willing to be genetically tested for mutations in the TTR gene
- Participants who have medical history of Heart failure secondary to hereditary or wild-type ATTR-CM
- New York Heart Association (NYHA) class I-III
- If on medical treatment for Heart Failure on stable dosage regimen for 2 weeks prior to randomization
- Willingness to adhere to vitamin A supplementation per protocol
You may not be eligible for this study if the following are true:
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- Acute coronary syndrome, unstable angina, stroke, TIA, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
- Those with hospitalization or urgent visit to ER/ED for worsening of HF
- Participants with uncontrolled hypertension
- Uncontrolled clinically significant cardiac arrhythmia
- Severe uncorrected cardiac valvular disease
- Cardiomyopathy not primarily caused by ATTR-CM
- Screening laboratory results as the protocol
- Active infection requiring systemic antiviral or antimicrobial therapy
- Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or hepatitis B
- History of bleeding, diathesis or coagulopathy
- If receiving oral anticoagulants, the dose must have been stable for 4 weeks prior to the first dose
- Those with malignancy within 5 years
- Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization
- Participants with known Light chain/Primary Amyloidosis or known leptomeningeal amyloidosis or known history of multiple myeloma
- Participants with anticipated survival < 2 years
- Treatment with another investigational drug and/or biological agent within 1 month of Screening, or 5 half-lives of investigational agent
- Current or previous treatment with TegsediTM (inotersen) or OnpattroTM (patisiran) or other oligonucleotide or RNA therapeutic (including siRNA)
- Current treatment with diflunisal, doxycycline, and/or calcium-channel blocker. Patients receiving any of these agents must respect a wash-out period of 14 days before randomization
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.