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Completed Phase 3 Interventional

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

ClinicalTrials.gov ID: NCT05819775

Public ClinicalTrials.gov record NCT05819775. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 16, 2026, 12:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema in Pediatric Subjects 2 to 11 Years of Age

Study identification

NCT ID
NCT05819775
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
CSL Behring
Industry
Enrollment
22 participants

Conditions and interventions

Interventions

  • CSL312 Biological

Biological

Eligibility (public fields only)

Age range
2 Years to 11 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 29, 2023
Primary completion
Nov 18, 2025
Completion
Nov 18, 2025
Last update posted
Jan 25, 2026

2023 – 2025

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
7
Facility City State ZIP Site status
Research Solutions of Arizona Litchfield Park Arizona 85340
Medical Research of Arizona Scottsdale Arizona 85251
Donald S. Levy M.D. Orange California 92868
Raffi Tachdjian MD, Inc. Santa Monica California 90404
Bernstein Clinical Research Cincinnati Ohio 45236
PennState Health Milton S. Hershey Medical Center Hershey Pennsylvania 17033
AARA Research Center Dallas Texas 75231

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05819775, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 25, 2026 · Synced May 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05819775 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →