RECRUITING

Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab

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

This study is designed to evaluate the safety after switching to garadacimab from another prophylactic hereditary angioedema (HAE) treatment (marketed kallikrein \[KK\] inhibitor or plasma-derived C1-esterase inhibitor \[pdC1INH\]prophylactic) when administered once monthly for approximately 3 months in participants aged greater than or equal to (\>=) 12 years with HAE.

Official Title

A Phase 4 Open-label Study to Evaluate the Safety After Switching to CSL312 (Garadacimab) From Current Prophylactic HAE Treatment in Subjects With HAE ≥ 12 Years of Age

Quick Facts

Study Start:2025-03-19
Study Completion:2026-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06806657

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. * Aged \>= 12 years at the time of providing written informed consent / assent.
  2. * Have a history of response to on-demand HAE treatment for the treatment of acute HAE attacks.
  3. * Documented laboratory diagnosis in medical records of C1-esterase inhibitor hereditary angioedema (HAE-C1INH) type 1 or type 2:
  4. * Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria),
  5. * C1-esterase inhibitor (C1INH) antigen concentration or functional activity less than (\<) 50% of normal as documented in the participant's medical record, or
  6. * C4-antigen concentration below the lower limit of the reference range as documented in the participant's medical record.
  1. * Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria.
  2. * Use of androgens, antifibrinolytics, or investigational products (other than garadacimab) for routine prophylaxis against HAE attacks.
  3. * Known or suspected hypersensitivity to monoclonal antibody therapy or hypersensitivity to the active substance (garadacimab) or to any of the excipients.

Contacts and Locations

Study Contact

Trial Registration Coordinator
CONTACT
+1 610-878-4697
clinicaltrials@cslbehring.com

Principal Investigator

Study Director
STUDY_DIRECTOR
CSL Behring

Study Locations (Sites)

Research Solutions of Arizona
Litchfield Park, Arizona, 85340
United States
Donald Levy M.D.
Orange, California, 92868
United States
Raffi Tachdjian MD, Inc.
Santa Monica, California, 90404
United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Study Director, STUDY_DIRECTOR, CSL Behring

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 Date2025-03-19
Study Completion Date2026-06-15

Study Record Updates

Study Start Date2025-03-19
Study Completion Date2026-06-15

Terms related to this study

Keywords Provided by Researchers

  • Autosomal dominant disease
  • Hereditary angioedema attack
  • Monoclonal antibody

Additional Relevant MeSH Terms

  • Hereditary Angioedema