Takeda: Alpha 1-Antitrypsin Deficiency trials

The registry lists 10 Alpha 1-Antitrypsin Deficiency studies with Takeda as lead sponsor. 0 are open to participants now and 6 have results posted.

Phase 1 3Phase 2 2Phase 3 2Phase 4 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.

• Stage 1 Study of ARALAST NP and GLASSIA in A1PI DeficiencyTerminatedNCT02722304Phase 3Results posted
• GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage StudyCompletedNCT02525861Phase 3Results posted
• GLASSIA Infusion Rate StudyCompletedNCT01651351Phase 4Results posted
• Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)CompletedNCT00396006Phase 4Results posted
• Aralast alpha1-proteinase Inhibitor Surveillance StudyTerminatedNCT00313144Phase 4Results posted
• Pharmacokinetic Study of ARALAST (Human Alpha1- PI)CompletedNCT00242385Phase 1Results posted
• A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-EmphysemaWithdrawnNCT05466747Phase 4
• ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) StudyWithdrawnNCT04440488Phase 4
• Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin DeficiencyCompletedNCT00161707Phase 1/2
• Study of the Effect of Aerosolized, Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes in Subjects With Alpha 1-Antitrypsin DeficiencyCompletedNCT00157092Phase 1/2