RECRUITING

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

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Conditions

Angioedema

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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

use of lanadelumab in patients with acquired angioedema

Official Title

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

Quick Facts

Study Start:2024-06-01
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06818474

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance)
  2. * historical attack rate of \>= on attack per month prior to starting tranexamic acid (TAA)
  1. * History of anaphylaxis or hypersensitivity to biologics
  2. * History of major systemic disease not well controlled in opinion of the PI
  3. * Women who are pregnant or breast feeding
  4. * Concurrent participation in other clinical trials
  5. * HAE Type 1 or 2 and normal complement HAE

Contacts and Locations

Study Contact

Karen Berendts
CONTACT
513-354-1746
kberendts@bernsteincrc.com
Jonathan Bernstein, MD
CONTACT
bernstja@ucmail.uc.edu

Principal Investigator

Jonathan Bernstein, MD
PRINCIPAL_INVESTIGATOR
5139314181

Study Locations (Sites)

Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
United States

Collaborators and Investigators

Sponsor: Bernstein Clinical Research Center

  • Jonathan Bernstein, MD, PRINCIPAL_INVESTIGATOR, 5139314181

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 Date2024-06-01
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Angioedema