Clinical trial
An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/Week and 120 mg/kg/Week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)
NCT07555483 is registered in ClinicalTrials.gov with Grifols Therapeutics LLC as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/Week and 120 mg/kg/Week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)
- Lead sponsor
- Grifols Therapeutics LLC
- Phase
- Phase 3
- Overall status
- Recruiting
- Start date
- May 5, 2026
- Completion date
- September 30, 2027
- Enrollment
- 40 (estimated)
- Sites
- 22
Conditions
As the registry lists them; a condition with its own page is linked.
alpha 1 antitrypsin deficiency