Trials / Terminated

TerminatedNCT04306510

A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN

A Phase 4 Safety Study Assessing the Adverse Events Occurring Within One Day of TEGSEDI Administration in Patients With Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR-PN)

Status: Terminated
Phase: Phase 4
Study type: Interventional
Enrollment: 8 (actual)

Sponsor: Akcea Therapeutics · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Hereditary Transthyretin Amyloidosis With Polyneuropthy

Interventions

Type	Name	Description
DRUG	TEGSEDI	SC injection.

Timeline

Start date: 2021-01-21
Primary completion: 2024-03-20
Completion: 2024-03-20
First posted: 2020-03-13
Last updated: 2025-04-10
Results posted: 2025-04-10

Locations

2 sites across 2 countries: United States, Canada

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04306510. Inclusion in this directory is not an endorsement.