A Phase 1 interventional study of nL-SAA1-01 in AA Amyloidosis, sponsored by Nelson Leung, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Nelson Leung, MD · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of a subcutaneous injection of nL-SAA1-01in a patient with AA Amyloidosis.
491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 304 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →This is the only study on the registry with Nelson Leung, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject will receive subcutaneous injection of nL-SAA1-01
Drug: nL-SAA1-01
Personalized antisense oligonucleotide
Adverse Events and/or serious adverse events
Number of adverse events and/or serious adverse events experienced
Time frame: 1 year
Change in kidney function
The change in kidney function is measured by the glomerular filtration rate (GFR)
Time frame: Baseline, 1 year
Change in quality of life - physical well-being
Physical well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life.
Time frame: Baseline, 1 year
Change in quality of life - emotional well-being
Emotional well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life.
Time frame: Baseline, 1 year
Change in quality of life - spiritual well-being
Spiritual well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life.
Time frame: Baseline, 1 year
Change in quality of life - intellectual well-being
Intellectual well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life.
Time frame: Baseline, 1 year
Change in quality of life - overall well-being
Overall well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life.
Time frame: Baseline, 1 year
Initiation of dialysis
The amount of time between the first dose of the investigational product and the need for dialysis
Time frame: 1 year
Initiation of kidney transplantation
The amount of time between the first dose of the investigational product and the need for a kidney transplantation.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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