drugset
drugset / Trial / NCT04440488

ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study

NCT04440488 ↗

Phase 4 Withdrawn Shire
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of ARALAST NP A1PI augmentation therapy 120 milligrams per kilogram (mg/kg) body weight (BW)/week compared with an external placebo comparator on the loss of emphysematous lung tissue measured by lung density change in participants with A1PI deficiency and COPD-E.

Timeline

Start
2021-03-08
Primary completion
2025-09-12
Completion
2025-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 60 mg/kg Intravenous
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 120 mg/kg Intravenous

Indications

alpha 1-antitrypsin deficiency chronic obstructive pulmonary disease