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Terminated Phase 3 Interventional Results available

Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency

ClinicalTrials.gov ID: NCT02722304

Public ClinicalTrials.gov record NCT02722304. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 5:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT02722304
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
7 participants

Conditions and interventions

Interventions

  • ARALAST NP 60 mg/kg Biological
  • ARALAST NP 120 mg/kg Biological
  • GLASSIA 60 mg/kg Biological
  • GLASSIA 120 mg/kg Biological
  • Human Albumin 2% Biological

Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 1, 2016
Primary completion
Sep 13, 2018
Completion
Sep 13, 2018
Last update posted
May 12, 2021

2016 – 2018

United States locations

U.S. sites
14
U.S. states
8
U.S. cities
14
Facility City State ZIP Site status
Phoenix Medical Research Institute, LLC Peoria Arizona 85381
Newport Native MD, Inc Newport Beach California 92663
Pulmonary Disease Specialists, P.A., / PDS Research Kissimmee Florida 34741
L&C Professional Medical Research Institute Miami Florida 33144
Loyola University Health System Maywood Illinois 60153
Indiana University Health Indianapolis Indiana 46202
La Porte County Institute for Clinical Research, Inc. Michigan City Indiana 46360
Pulmonary Health Physicians Fayetteville New York 13066
Clinical Research of Gastonia Gastonia North Carolina 28054
Southeastern Research Center LLC Winston-Salem North Carolina 27103
Metroplex Pulmonary and Sleep Center Allen Texas 75013
Houston Pulmonary and Sleep Associates Houston Texas 77065
Element Research Group San Antonio Texas 78258
Renovatio Clinical-Respiratory & Sleep Disorders Specialists The Woodlands Texas 77005

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02722304, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 12, 2021 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02722304 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →