The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients With Non-V30M Transthyretin Amyloidosis

Exclusion Criteria

• •Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted).
• •Patient has primary or secondary amyloidosis.
• •Patient has TTR-associated amyloidosis with V30M mutation.
• •If female, patient is pregnant or breast feeding.
• •Patient has received prior liver transplantation.
• •Patient is expected to undergo liver transplantation within 12 months after enrollment.
• •Patient with positive results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).
• •Patient has renal insufficiency (creatinine clearance \< 30 ml/min).
• •Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) \> 2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.
• •Patient has a New York Heart Association (NYHA) Functional Classification ≥ III.
• •Patient has other causes of sensorimotor neuropathy (B12 deficiency, Diabetes Mellitus, HIV treated with retroviral medications, thyroid disorders, alcohol abuse, and chronic inflammatory diseases).
• •Patient has prior non-amyloid cardiac disease such as: myocardial infarction due to obstructive coronary artery disease, active non-amyloid cardiomyopathy (e.g., symptomatic left ventricular dysfunction from any cause other than amyloid, patients with a primary diagnosis of symptomatic valvular heart disease)
• •Patient has a co-morbidity anticipated to limit survival to less than 12 months.
• •Patient has received an investigational drug/device and/or participated in another clinical investigational study within 60 days before Baseline (Day 0).