NCT00301366

The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency

Multi-center, Open-label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-antitrypsin (AAT) Deficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alpha 1-Antitrypsin Deficiency

Interventions

Type	Name	Description
DRUG	alpha-1 proteinase inhibitor (human)	60 mg/kg weekly for 20 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2006-03-10
• Last updated: 2014-08-19
• Results posted: 2014-08-19

Locations

10 sites across 2 countries: United States, United Kingdom