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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

18-75 Years
18+ Years
All
All

Not accepting

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?

Yes

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.
No

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.

Locations

Location

Status

For more information, view the full study details:

NCT058996732023-503497-21