Fazirsiran for Alpha-1 Antitrypsin Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing fazirsiran, a drug that may reduce liver scarring and improve liver health, in patients with liver fibrosis. The drug works by decreasing harmful proteins and reducing inflammation in the liver.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
Adults aged 18-75 with Alpha-1 Antitrypsin Deficiency (AATD) causing liver scarring, who are non-smokers for at least a year and have a BMI of 18.0-39.0 kg/m2 can join this trial. They must not have liver cancer, drug abuse history within the last year, certain blood or liver issues, other chronic liver diseases, recent malignancies except some skin cancers or in situ cervical cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fazirsiran or placebo via subcutaneous injection on Day 1, at Week 4, and then every 12 weeks thereafter up to Week 196
Follow-up
Participants are monitored for safety and effectiveness after treatment, including liver biopsies and assessments of liver function and fibrosis
What Are the Treatments Tested in This Trial?
Interventions
- Fazirsiran Injection
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
Takeda Development Center Americas, Inc.
Industry Sponsor