CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

ClinicalTrials.gov ID: NCT04656418

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Official title

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.

Study identification

NCT ID: NCT04656418
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: CSL Behring; Industry
Enrollment: 64 participants

Conditions and interventions

Conditions

Hereditary Angioedema

Interventions

CSL312 Biological
Placebo Drug

Biological · Drug

Eligibility (public fields only)

Age range: 12 Years and older
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: Jan 27, 2021 (Actual)
Primary completion: Jun 7, 2022 (Actual)
Completion: Jun 7, 2022 (Actual)
Last update posted: Jun 29, 2023

2021 – 2022

United States locations

U.S. sites: 8
U.S. states: 7
U.S. cities: 8

Facility	City	State	ZIP	Site status
Clinical Research Center of Alabama	Birmingham	Alabama	35209	—
Medical Research of Arizona	Scottsdale	Arizona	85251	—
Raffi Tachdjian MD, Inc.	Santa Monica	California	90404	—
Allergy and Asthma Clinical Research	Walnut Creek	California	94598	—
Institute of Asthma and Allergy	Chevy Chase	Maryland	20815	—
Bernstein Clinical Research Center LLC	Cincinnati	Ohio	45231	—
Pennsylvania State University	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 20 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04656418, 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 Jun 29, 2023 · Synced Nov 12, 2026