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NCT05677971 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Alpha1-Antitrypsin Deficiency, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT05677971 is a Phase 3 study of Alpha1-Antitrypsin Deficiency that is actively recruiting participants, run by Takeda. The registered enrollment target is 160 participants, above the 128-participant average among 5 other Alpha1-Antitrypsin Deficiency trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT05677971, a Phase 3 study of Alpha1-Antitrypsin Deficiency, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Fazirsiran Injection
Study Locations (20)
California
- Gastroenterology & Liver Institute - Escondido
- University of California San Diego, Altman Clinical and Translational Institute - La Jolla
- UCLA Pulmonary and Critical Care - Los Angeles
- Stanford University - Palo Alto
- University of California Benioff Children's Hospital - San Francisco
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
- Mayo Clinic - Phoenix
- University of Arizona Thomas D. Boyer Liver Institute - Tucson
Florida
- University of Florida - Gainesville
- Schiff Center for Liver Diseases/University of Miami - Miami
Massachusetts
- Brigham and Womens Hospital - Boston
- Boston Medical Center - Boston
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Peak Gastroenterology Associates, PC - Colorado Springs
Georgia
- Children's Healthcare of Atlanta - Atlanta
Indiana
- Indiana University School of Medicine - Indianapolis - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2030-08-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05677971
The ClinicalTrials.gov registry entry for NCT05677971 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 128-participant average among 5 other Alpha1-Antitrypsin Deficiency trials with a reported enrollment target (25% higher). 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 2 interventions - of which Placebo is the first listed.
NCT05677971 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05677971 about?
NCT05677971 is a clinical study titled "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". The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran red...
What is the current status of trial NCT05677971?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2023-03-06. Estimated completion is 2030-08-14.
What conditions does trial NCT05677971 study?
This clinical trial studies the following conditions: Alpha1-Antitrypsin Deficiency.
What interventions are being tested in trial NCT05677971?
The interventions under investigation include: Placebo (OTHER), Fazirsiran Injection (DRUG).
Who is sponsoring clinical trial NCT05677971?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05677971 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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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