An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease
Sponsored by Takeda
About this trial
Last updated 3 months ago
Study ID
TAK-999-3003
Status
Active, not recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 2 years ago
What is this trial about?
The main aim of this study is to learn if fazirsiran is safe during long-term use in
people with liver disease caused by the abnormal Z-alpha-1 antitrypsin (Z-AAT) protein.
People who have taken part in previous fazirsiran studies (AROAAT2001 [NCT03945292] or
AROAAT2002 [NCT03946449]) can continue to receive fazirsiran every 3 months as long as
they participate in this study, the study is ongoing or until health authorities in their
country approve fazirsiran to be publicly available. The study may also provide
information on whether fazirsiran has a long-term effect in reducing liver fibrosis or
slowing down the progression of liver fibrosis in people with liver disease due to the
abnormal Z-AAT protein.
What are the participation requirements?
Inclusion Criteria
Men and women who are 18 to 75 years old can participate in the study:
Must either currently take part in the AROAAT2001 or AROAAT2002 studies or have completed the
AROAAT2001 or AROAAT2002 studies within the last 6 months.
Must have acceptable lung function.
Must be a nonsmoker for at least the last 4 months. This will be confirmed by a urine test.
Must not have liver cancer.
Exclusion Criteria
Cannot be likely to have major surgery.
Cannot have had symptoms or signs of liver failure, or some other types of chronic liver disease.
Additional entry criteria will be discussed with the study doctor.