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

NCT04306510 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-04-10

Study results available
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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

DRUG

TEGSEDI

SC injection.

Sponsors & Collaborators

  • Akcea Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2024-03-20
Completion
2024-03-20
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04306510 on ClinicalTrials.gov