ACTIVE_NOT_RECRUITING

A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

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Conditions

Hereditary AngioedemaHAE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).

Official Title

An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

Quick Facts

Study Start:2022-07-13
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05392114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Ionis Investigative Site
Paradise Valley, Arizona, 85253
United States
Ionis Investigative Site
La Jolla, California, 92037
United States
Ionis Investigative Site
Santa Monica, California, 90404
United States
Ionis Investigative Site
Walnut Creek, California, 94598
United States
Ionis Investigative Site
Tampa, Florida, 33613
United States
Ionis Investigative Site
Kansas City, Kansas, 66103
United States
Ionis Investigative Site
Boston, Massachusetts, 02114
United States
Ionis Investigative Site
Ann Arbor, Michigan, 48109
United States
Ionis Investigative Site
Detroit, Michigan, 48202
United States
Ionis Investigative Site
Saint Louis, Missouri, 63141
United States
Ionis Investigative Site
Mooresville, North Carolina, 28117
United States
Ionis Investigative Site
Cincinnati, Ohio, 45236
United States
Ionis Investigative Site
Columbus, Ohio, 43235
United States
Ionis Investigative Site
Hershey, Pennsylvania, 17033
United States
Ionis Investigative Site
Dallas, Texas, 75231
United States
Ionis Investigative Site
Murray, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Ionis Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13
Study Completion Date2027-03

Study Record Updates

Study Start Date2022-07-13
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • HAE

Additional Relevant MeSH Terms

  • Hereditary Angioedema