A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin DeficiencyAssociatedLiver Disease With METAVIR Stage F2 to F4 Fibrosis
Sponsor: |
Takeda Development Center Americas, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU4096 |
U.S. Govt. ID: |
NCT05677971 |
Contact: |
Transplant Clinical Research Center TCRC: / tcrcstudyreferral@cumc.columbia.edu |
The main purpose of this study is to determine how safe and effective fazirsiran is in patients with alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD) compared to placebo. Eligible participants will receive either fazirsiran or placebo for about 4 years. This is a double-blind study, so the study doctors and participants will not know whether or not they are receiving fazirsiran or placebo. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
This study is closed
Investigator
Dana Goldner, MD
Are you between 18 and 75 years old? |
Yes |
No |
Do you have a diagnosis of alpha-1 antitrypsin deficiency (AATD)? |
Yes |
No |