Condition: Alpha1-Antitrypsin Deficiency · Sponsor: Takeda
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.
This description comes directly from the study's public registry record.
Takeda Contact · 1-877-825-3327 · medinfoUS@takeda.com
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| University of Alabama at Birmingham | Birmingham, Alabama, United States | Recruiting |
| St. Joseph's Hospital and Medical Center | Phoenix, Arizona, United States | Recruiting |
| Mayo Clinic | Phoenix, Arizona, United States | Recruiting |
| University of Arizona Thomas D. Boyer Liver Institute | Tucson, Arizona, United States | Withdrawn |
| Gastroenterology & Liver Institute | Escondido, California, United States | Withdrawn |
| University of California San Diego, Altman Clinical and Translational Institute | La Jolla, California, United States | Recruiting |
| UCLA Pulmonary and Critical Care | Los Angeles, California, United States | Recruiting |
| Stanford University | Palo Alto, California, United States | Recruiting |
| University of California Benioff Children's Hospital | San Francisco, California, United States | Recruiting |
| Peak Gastroenterology Associates, PC | Colorado Springs, Colorado, United States | Recruiting |
| University of Florida | Gainesville, Florida, United States | Recruiting |
| Schiff Center for Liver Diseases/University of Miami | Miami, Florida, United States | Recruiting |
+ 77 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05677971