Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency

Summary

This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous infusions of 60 mg/kg of Alpha-1 MP (alpha1-proteinase inhibitor (human), modified process) for 8 weeks.

Timeline

Start

2016-07-29

Primary completion

2017-03-15

Completion

2017-03-15

Publications

• Seyama K, Nukiwa T, Sato T, Suzuki M, Konno S, Takahashi K, Nishimura M, Steinmann K, Sorrells S, Chen J, Hayashi KI. Safety and pharmacokinetics of Alpha-1 MP (Prolastin(R)-C) in Japanese patients with alpha1-antitrypsin (AAT) deficiency. Respir Investig. 2019 Jan;57(1):89-96. doi: 10.1016/j.resinv.2018.09.006. Epub 2018 Nov 8.

Drugs

Indications