4 results
The main objective of the study is to determine the PK and PD of IVIg during maintenance treatment in patients with CIDP. These data will be used to conduct a NONMEM analysis in relation to the dosage, frequency and batch of IVIg used. The secondary…
The objective of this study is to determine the efficacy, safety, and tolerability of tafamidis in subjects with transthyretin cardiomyopathy.The primary objective is to assess the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg…
To obtain additional, long term, safety data for tafamidis in subjects with transthyretin amyloid cardiomyopathy (ATTR CM). To provide investigational product, tafamidis, to ATTR CM subjects who complete 30 months of blinded treatment on protocol…
To assess safety and performance of the LithiX Coronary HCIVLC to treat moderately to severely calcified coronary artery lesions by calcium fragmentation utilizing Hertzian contact stress from LithiX HCIVLC.