Grifols: alpha 1-Antitrypsin Deficiency trials

The registry lists 12 alpha 1-Antitrypsin Deficiency studies with Grifols as lead sponsor. 2 are open to participants now and 9 have results posted.

Phase 1 3Phase 2 7Phase 3 5(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• 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)RecruitingNCT07555483Phase 3
• Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin DeficiencyEnrolling by invitationNCT02796937Phase 3
• A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin DeficiencyCompletedNCT04722887Phase 1/2Results posted
• Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)CompletedNCT02870348Phase 1/2Results posted
• Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin DeficiencyCompletedNCT02870309Phase 1/2Results posted
• Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes MellitusTerminatedNCT02093221Phase 2Results posted
• Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic FibrosisCompletedNCT01684410Phase 2Results posted
• Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin DeficiencyCompletedNCT01213043Phase 2Results posted
• The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) DeficiencyCompletedNCT00301366Phase 3Results posted
• Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient AdultsCompletedNCT00295061Phase 3Results posted
• Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)CompletedNCT00263887Phase 2Results posted
• Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)CompletedNCT01983241Phase 3