A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
Completed · Phase 1, Phase 2 · NCT04722887
Conditions: Alpha1-Antitrypsin Deficiency
At a glance
- Research payments reported, 2025
- $281,896
- U.S. investigators named
- 6
- Sites paid
- 6
- Planned or actual enrollment
- 17
About the trial
- Sponsor
- Grifols Therapeutics LLC
- Tested
- Alpha-1 15% (biological), Liquid Alpha1-Proteinase Inhibitor (Human) (biological)
- Dates
- Started 2021-12-16; completion 2025-08-01
- Results posted
- Yes
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD).
From ClinicalTrials.gov, last updated 2026-10-08. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Grifols Therapeutics LLC reported $281,896 in research payments for this study in 2025 (25 payments).
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
- Igor Barjaktarevic, M.D., M.SC Pulmonology · Los Angeles, CA
- Michael A. Campos, M.D. Critical Care Medicine · Miami, FL
- Jorge E. Lascano, MD Critical Care Medicine · Gainesville, FL
- Vickram Tejwani, M.D. Pulmonology · Cleveland, OH
- Charlton B. Strange, MD Critical Care Medicine · Charleston, SC
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Ronald Reagan UCLA Medical Center, CA $124,172
- Cleveland Clinic, OH $77,361
- Medical University of South Carolina $63,609
- University of Miami $9,857
- St Josephs Hospital and Medical Center, AZ $6,687
- University of Florida Department of Epidemiology $209
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.