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NCT06165341 · ClinicalTrials.gov registry record · Phase 3
Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis)
A Phase 3 study of Alpha-1 Antitrypsin Deficiency, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT06165341: Recruiting Phase 3 study of Alpha-1 Antitrypsin Deficiency, sponsored by Takeda.
NCT06165341 is a Phase 3 study of Alpha-1 Antitrypsin Deficiency that is actively recruiting participants, run by Takeda. The registered enrollment target is 50 participants, below the 2,340-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06165341, a Phase 3 study of Alpha-1 Antitrypsin Deficiency, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study Summary
The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver cells, which leads to liver problems such as liver scarring (fibrosis), continuing liver damage (cirrhosis), and eventually end stage liver disease. Fazirsiran is a medicine that reduces the creation of the Z-AAT protein and thus the build-up of this abnormal protein in the liver. People with this type of liver disease who already have mild liver scarring will take part in the study. They will be treated with fazirsiran or a placebo for about 2 years. This study will check the long-term safety of fazirsiran, whether participants tolerate the treatment and if there are any effects on liver scarring. A liver biopsy, a way of collecting a small tissue sample from the liver, will be taken twice during the study.
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 Placebo
- DRUG Fazirsiran Injection
Study Locations (20)
Arizona
- St Joseph's Hospital and Medical Center - Phoenix
- Mayo Clinic - PPDS - Phoenix
- University of Arizona Thomas D. Boyer Liver Institute - Tucson
California
- University of California San Diego - La Jolla
- UCLA Pulmonary and Critical Care - Los Angeles
- University of California Benioff Children's Hospital - San Francisco
Michigan
- University of Michigan Hospital - 1500 E Medical Center Dr - Ann Arbor
- Henry Ford Health System - Novi
New York
- NYU Langone Medical Center - New York
- Columbia University Irving Medical Center - New York
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Florida
- Schiff Center for Liver Diseases/University of Miami - Miami
Indiana
- Indiana University School of Medicine-Indianapolis - Indianapolis
Iowa
- University Of Iowa Hospitals And Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2028-08-26 |
| Phase | Phase 3 |
What NCT06165341 shows while recruiting
NCT06165341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,340-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Alpha-1 Antitrypsin Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06165341 names 20 study sites across 14 states, led by Arizona, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT06165341 about?
NCT06165341 is a clinical study titled "Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis)". The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver ce...
What is the current status of trial NCT06165341?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2024-03-01. Estimated completion is 2028-08-26.
What conditions does trial NCT06165341 study?
This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT06165341?
The interventions under investigation include: Placebo (DRUG), Fazirsiran Injection (DRUG).
Who is sponsoring clinical trial NCT06165341?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06165341 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Indiana. 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 NCT06165341's enrollment target sits among peer trials
50 13th of 24 higher than 12 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
-
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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An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease
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