Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis

Completed · Phase 2

Conditions studied: TTR-mediated Amyloidosis

In brief

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.

Key facts

Study ID

NCT01981837

Run by

Alnylam Pharmaceuticals

People needed

26

Starts

2013-12-01

Expected to finish

2015-01-01

Last updated by the study team

2023-03-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trial Site — Boston, Massachusetts, United States
• Clinical Trial Site — New York, New York, United States
• Clinical Trial Site — Cleveland, Ohio, United States
• Clinical Trial Site — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.