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NCT04306510 · ClinicalTrials.gov registry record · Phase 4
A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN
A Phase 4 study, sponsored by Akcea Therapeutics.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT04306510: Clinical Trial Phase 4 study, sponsored by Akcea Therapeutics.
NCT04306510 is a Phase 4 study that was terminated before completion, run by Akcea Therapeutics. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04306510, a Phase 4 study, was terminated before completion, sponsored by Akcea Therapeutics.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
The objective of the study was to characterize adverse events (AEs) occurring within one day of TEGSEDI administration to adult participants with hATTR-PN overall and in individual participants with respect to time course of AE onset, vital sign changes, preventive measures, treatment required, risk factors, and subsequent adverse outcomes.
Primary Outcome
An adverse event (AE) is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medicinal product, whether or not the AE is considered related to the medicinal product. TEAEs are defined as AEs with an onset date/time on or after the date/time of the first on study administration of TEGSEDI.
Interventions
- DRUG TEGSEDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2024-03-20 |
| Phase | Phase 4 |
Why NCT04306510 stopped before completion
NCT04306510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which TEGSEDI is the first listed.
NCT04306510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04306510 about?
NCT04306510 is a clinical study titled "A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN". The objective of the study was to characterize adverse events (AEs) occurring within one day of TEGSEDI administration to adult participants with hATTR-PN overall and in individual participants with respect to time course of AE onset, vital sign changes, preventive measures, treatment required, risk...
What is the current status of trial NCT04306510?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2021-01-21. Estimated completion is 2024-03-20.
What interventions are being tested in trial NCT04306510?
The interventions under investigation include: TEGSEDI (DRUG).
Who is sponsoring clinical trial NCT04306510?
This trial is sponsored by Akcea Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04306510's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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