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NCT06512454 · ClinicalTrials.gov registry record
A Study in Adults to Learn About Inherited Alpha-1 Antitrypsin Deficiency (AATD) and AATD Related Liver Problems
A clinical trial of Alpha-1 Antitrypsin Deficiency, sponsored by Takeda.
- Recruiting
- Registry status
- 500
- Enrollment target
- 2
- Study locations
NCT06512454: Recruiting study of Alpha-1 Antitrypsin Deficiency, sponsored by Takeda.
NCT06512454 is a study of Alpha-1 Antitrypsin Deficiency that is actively recruiting participants, run by Takeda. The registered enrollment target is 500 participants, below the 2,321-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06512454, a study of Alpha-1 Antitrypsin Deficiency, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 2
- Study locations
Study Summary
The main aim of this study is to learn about liver problems caused by the lack of alpha-1 antitrypsin (called Alpha-1 Antitrypsin Deficiency or AATD) in adults when not treated (this is called the natural history of a condition) over 5 years. Other aims are to learn what can predict the AATD-liver condition starting and getting better or worse, describe how this condition is currently being diagnosed and watched in normal hospital care, and describe how the AATD also affects and adult's lung function. Data in this study will be collected to include medical history of a participant, including the date AATD was first identified and/or the date on which the first AATD-related liver or lung problems were diagnosed. At study start and then every year until study end, participants will be asked to completed questionnaires (called patient-reported outcomes or PRO).
Primary Outcome
Liver disease progression will be defined as advancement in greater than or equal to (\>=)1 fibrosis stage: example any progression from fibrosis stage F0/F1 to F2, F1 to F2, F2 to F3 etc. and/or occurrence of any of these composite events: a) advancement in \>=1 fibrosis stage, b) development of a liver disease-related clinical event, c) model for end-stage liver disease (MELD) score increase, d) newly added on liver transplant list, e) receipt of a liver transplant. The fibrosis stages range f
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (2)
Florida
- University of Florida - Gainesville
North Rhine-Westphalia
- Universitätsklinikum Aachen AöR - Aachen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-09-25 |
| Est. Completion | 2032-04-06 |
What NCT06512454 shows while recruiting
NCT06512454 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 2,321-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Alpha-1 Antitrypsin Deficiency appearing as the primary indexed condition, and to 1 intervention - of which No Intervention is the first listed.
NCT06512454 reports a single indexed study location in Florida, North Rhine-Westphalia.
Frequently Asked Questions
What is clinical trial NCT06512454 about?
NCT06512454 is a clinical study titled "A Study in Adults to Learn About Inherited Alpha-1 Antitrypsin Deficiency (AATD) and AATD Related Liver Problems". The main aim of this study is to learn about liver problems caused by the lack of alpha-1 antitrypsin (called Alpha-1 Antitrypsin Deficiency or AATD) in adults when not treated (this is called the natural history of a condition) over 5 years. Other aims are to learn what can predict the AATD-liver c...
What is the current status of trial NCT06512454?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2024-09-25. Estimated completion is 2032-04-06.
What conditions does trial NCT06512454 study?
This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT06512454?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT06512454?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06512454 being conducted?
This trial has 2 study locations across Florida, 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
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Where NCT06512454's enrollment target sits among peer trials
500 3rd of 24 higher than 22 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.
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