Grifols Therapeutics LLC
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).
This is a 2-year open-label extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha-1 MP 60 mg/kg/week in subjects with AATD. The study consists of a Screening Visit (the same visit as the End-of-Study Visit in the GTi1201 study for subjects who complete the GTi1201 study or is the same visit as the Early Discontinuation Visit for subjects meeting the early withdrawal criterion for forced expiratory volume in 1 second \[FEV1\] decline), a treatment period of 104 weeks (beg…
Inclusion Criteria: * Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160/End-of-Study Visit) OR has experienced a decline in FEV1 at the annualized rate of ≥134.4 mL/year at or after the Week 104 Visit in GTi1201. * Is willing and able to provide informed consent Exclusion Criteria: * Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic). * Has severe concomitant disease including, but not limited to, congestive heart failure and liver cirrhosis. * Has primary and/or secondary (metastatic disease) pulmo…
Alpha-1 MP 60 mg/kg/week for up to 104 weeks