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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 Alpha1-Antitrypsin Deficiency, sponsored by Takeda.
- Active
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
- 10
- Study locations
NCT05899673 is a Phase 3 study of Alpha1-Antitrypsin Deficiency that is active but no longer recruiting, run by Takeda. The registered enrollment target is 31 participants, below the 154-participant average among 5 other Alpha1-Antitrypsin Deficiency trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 6 states.
The verdict
NCT05899673, a Phase 3 study of Alpha1-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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05899673
The ClinicalTrials.gov registry entry for NCT05899673 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 154-participant average among 5 other Alpha1-Antitrypsin Deficiency trials with a reported enrollment target (80% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alpha1-Antitrypsin Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Fazirsiran Injection is the first listed.
NCT05899673 reports 10 study locations spanning 6 distinct geographic areas - top geographies include 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: Alpha1-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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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