Active Clinical Trials

Clinical Trials

REDWOOD (NCT05677971)

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

A Phase 3 trial testing fazirsiran, an RNA interference therapy, in adults with AATD-associated liver disease with moderate to advanced scarring (METAVIR F2–F4). Participants receive fazirsiran or placebo by injection over approximately 2 years, with liver biopsies to measure whether the treatment reduces scarring.

TAK-999-3002 (NCT06165341)

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F1 Fibrosis

Phase 3 Trial targeting patients with earlier-stage liver scarring (METAVIR F1), this Phase 3 trial tests whether fazirsiran can prevent progression before significant damage has occurred. It began in March 2024 and is expected to run through August 2028.

TAK-999-3003 (NCT05899673)

A Phase 3, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Fazirsiran in Participants With Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

An open-label Phase 3 extension study for patients who completed earlier fazirsiran trials, allowing them to continue receiving the drug every 3 months for the long term. Its primary goal is to assess the long-term safety of fazirsiran and whether its benefits on liver scarring are sustained over time.

SPARTA (Study of ProlAstin-c Randomized Therapy with Alpha-1 augmentation)

A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1 Proteinase Inhibitor (Human) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency

A Phase 3 trial testing two doses of Prolastin-C (60 mg/kg and 120 mg/kg, given by weekly IV infusion) against placebo in patients with AATD-related emphysema across more than 50 sites in 16 countries. Lung tissue loss is measured by CT scan over 3 years to determine whether the standard or doubled dose better slows disease progression.