Transthyretin Amyloid Cardiomyopathy Clinical Trial
Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Summary
The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR) Cardiac Amyloidosis.
Eligibility Criteria
Inclusion Criteria:
TTR cardiac amyloidosis;
Women of child-bearing potential (WOCBP) must have a negative pregnancy test, cannot be breast feeding, and must be willing to use 2 highly effective methods of contraception;
Male subjects agree to use appropriate contraception;
Adequate blood counts, liver, renal and heart function;
Adequate Karnofsky performance status;
Adequate New York Heart Association (NYHA) Classification Score;
Clinically stable on heart medications;
Adequate 6-minute walk test;
Willing to give written informed consent and are willing to comply with the study requirements.
Exclusion Criteria:
Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;
Subjects with a history of multiple drug allergies or intolerance to SC injection;
Received an investigational agent other than tafamidis, diflunisal, doxycycline or tauroursodeoxycholic acid, or an investigational device within 30 days prior to first dose of study;
Uncontrolled hypertension, ischemic heart disease or cardiac arrhythmia;
Untreated hypo- or hyperthyroidism;
Prior major organ transplant;
Considered unfit for the study by the Principal Investigator.
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There are 4 Locations for this study
Boston Massachusetts, 02155, United States
New York New York, 10034, United States
Cleveland Ohio, 44195, United States
London , UK NW, United Kingdom
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