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ACTIVE NOT RECRUITING 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

NCT05899673 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 31 participants
Start Date 2023-08-08
Est. Completion 2033-05-02
Phase Phase 3

Sponsor

Takeda

387 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05899673 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05899673?

The interventions under investigation include: Fazirsiran Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05899673?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial