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NCT05899673 · ClinicalTrials.gov registry record · Phase 3
An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease
A Phase 3 study of Alpha-1 Antitrypsin Deficiency, sponsored by Takeda.
- Active
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
- 10
- Study locations
NCT05899673: Active Phase 3 study of Alpha-1 Antitrypsin Deficiency, sponsored by Takeda.
NCT05899673 is a Phase 3 study of Alpha-1 Antitrypsin Deficiency that is active but no longer recruiting, run by Takeda. The registered enrollment target is 31 participants, below the 2,341-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05899673, a Phase 3 study of Alpha-1 Antitrypsin Deficiency, is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not it is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study intervention. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpati
Conditions Studied
Interventions
- DRUG Fazirsiran Injection
Study Locations (10)
Other
- Medizinische Universitat Wien (Medical University of Vienna) - Vienna
- Hospital Nélio Mendonça - Funchal
- Addenbrooke's Hospital - Cambridge
- Royal Infirmary of Edinburgh - PPDS - Edinburgh
California
- UCSD Altman Clinical and Translational Research Institute - La Jolla
- Stanford Medicine Outpatient Center - Redwood City
Florida
- UF Clinical and Translational Science Institute - Gainesville
Iowa
- University Of Iowa Hospitals And Clinics - Iowa City
South Carolina
- Medical University of South Carolina - Hollings Cancer Center - PPDS - Charleston
North Rhine-Westphalia
- Universitätsklinikum der RWTH Aachen - Aachen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2033-05-02 |
| Phase | Phase 3 |
What the registry record for NCT05899673 still lists
NCT05899673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 2,341-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alpha-1 Antitrypsin Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Fazirsiran Injection is the first listed.
NCT05899673 lists 10 locations in 6 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT05899673 about?
NCT05899673 is a clinical study titled "An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease". 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 contin...
What is the current status of trial NCT05899673?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2023-08-08. Estimated completion is 2033-05-02.
What conditions does trial NCT05899673 study?
This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT05899673?
The interventions under investigation include: Fazirsiran Injection (DRUG).
Who is sponsoring clinical trial NCT05899673?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05899673 being conducted?
This trial has 10 study locations across California, Florida, Iowa, South Carolina, North Rhine-Westphalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alpha-1 Antitrypsin Deficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05899673's enrollment target sits among peer trials
31 17th of 24 higher than 8 of 24 other Alpha-1 Antitrypsin Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alpha-1 Antitrypsin Deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein
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