NCT02722304

Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency

A Stage 1, Prospective, Randomized, Placebo-Controlled, Double- Blind Study to Evaluate the Safety and Efficacy of Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).

Conditions

• Chronic Obstructive Pulmonary Disease
• Alpha1-antitrypsin Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	ARALAST NP 60 mg/kg	ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
BIOLOGICAL	ARALAST NP 120 mg/kg	ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
BIOLOGICAL	GLASSIA 60 mg/kg	GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
BIOLOGICAL	GLASSIA 120 mg/kg	GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
BIOLOGICAL	Human Albumin 2%	Human albumin 2% (by appropriate dilution with normal saline solution)

Timeline

• Start date: 2016-11-02
• Primary completion: 2018-09-14
• Completion: 2018-09-14
• First posted: 2016-03-30
• Last updated: 2021-05-13
• Results posted: 2019-10-08

Locations

17 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study