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NCT04134299 · ClinicalTrials.gov registry record · NA
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
A NA study, sponsored by Axcella Health.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04134299: Completed NA study, sponsored by Axcella Health.
NCT04134299 is a NA study that has completed, run by Axcella Health. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04134299, a NA study, has completed, sponsored by Axcella Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks. The study also assesses the effects of this amino acid composition on the structure and function of the vascular system. Physiological effects on structure and function will be assessed by Magnetic Resonance Imaging (MRI) to assess blood flow in the brain and kidneys and the 6-Minute walk with pulse oximetry. Changes in blood biomarkers of inflammation will also be assessed.
Primary Outcome
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Interventions
- DIETARY_SUPPLEMENT AXA4010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2021-01-11 |
| Phase | NA |
What the finished NCT04134299 record still lists
NCT04134299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which AXA4010 is the first listed.
NCT04134299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04134299 about?
NCT04134299 is a clinical study titled "To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease". This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks. The study also assesses the effects of this amino acid composition on the structure and function of the vascul...
What is the current status of trial NCT04134299?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2019-09-25. Estimated completion is 2021-01-11.
What interventions are being tested in trial NCT04134299?
The interventions under investigation include: AXA4010 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04134299?
This trial is sponsored by Axcella Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04134299's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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