Conditions: Alpha 1-Antitrypsin Deficiency
Keywords: alpha 1-Antitrypsin Deficiency alpha 1-Antitrypsin pulmonary emphysema
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

Brief summary:
The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

Detailed description:
The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. The primary objective is to describe the nature and frequency of treatment-emergent adverse events with "treatment-emergent" defined as any adverse event occurring after the start of the first study drug infusion.

Arms:
arm 1: Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects.

Interventions: intervention 1: alpha-1 proteinase inhibitor (human)
Intervention descriptions: intervention 1: 60 mg/kg weekly for 20 weeks

Protocol document: