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A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)

Study acronym: SWIFT-SC
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 22 sitesv4
  2. Trial sites expanded: 19 → 22 locationsv3
  3. Primary and study completion pushed from Sep 29, 2026 to Sep 30, 2027
    • Recruitment opened
    • Start date changed from estimate of Apr 21, 2026 to May 5, 2026
    • Site details revised at 19 of 19 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Grifols Therapeutics LLC
7 trials monitored
See 1 trial at risk
COPD
1,119 trials monitored
See 34 trials at risk
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein. Adults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given. The main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.
Trial Details
NCT Number NCT07555483
Lead Sponsor Grifols Therapeutics LLC
Conditions
(from sponsor)		 Alpha 1 Antitrypsin Deficiency
Related terms alpha 1-Antitrypsin Deficiency, Emphysema, Genetic Diseases, Inborn, Lung Diseases, Lung Diseases, Obstructive, Pathologic Processes, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Respiratory Tract Diseases, Subcutaneous Emphysema
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov