Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
Completed · Phase 3 · NCT01983241
Conditions: Pulmonary Emphysema in Alpha-1 PI Deficiency
At a glance
- Research payments reported, 2025
- $34,434
- U.S. investigators named
- 3
- Sites paid
- 3
- Planned or actual enrollment
- 345
About the trial
- Sponsor
- Grifols Therapeutics LLC
- Tested
- Alpha-1 MP (biological), 0.9% Sodium Chloride for Injection, USP (other)
- Dates
- Started 2014-04-01; completion 2026-08-05
- Results posted
- Not yet
This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
From ClinicalTrials.gov, last updated 2026-10-01. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Grifols Therapeutics LLC reported $34,434 in research payments for this study in 2025 (5 payments).
Products named: Prolastin-C Liquid
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Rajat Walia, MD Pulmonology · Phoenix, AZ
- Alan F. Barker, MD Pulmonology · Portland, OR
- James M. Stocks, MD Pulmonology · Tyler, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.