Hereditary Angioedema (HAE)

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

NCT05819775 | Phase 3 | Interventional

The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.

11 Sites

20 Participants

Recruiting

2 Years to 11 Years

If interested, contact clinicaltrials@cslbehring.com for more information

Find closest sites:

SUBMIT

Research Solutions of Arizona

Litchfield Park,Arizona,United States,85340

Medical Research of Arizona

Scottsdale,Arizona,United States,85251

Donald S. Levy M.D.

Orange,California,United States,92868

Raffi Tachdjian MD, Inc.

Santa Monica,California,United States,90404

Bernstein Clinical Research

Cincinnati,Ohio,United States,45236

AARA Research Center

Dallas,Texas,United States,75231

Campbelltown Hospital, Western Sydney University

Campbelltown,Australia,NSW 2560

Ottawa Allergy Research Corp

Ottawa,Canada,K1H1E4

HZRM Hmophilie Zentrum Rhein Main GmbH

Frankfurt am Main,Germany,60596

Charit Universittsmedizin Berlin

Berlin,Germany,12203

Barzilai University Medical Center

Ashkelon,Israel,7830604

Inclusion Criteria

Exclusion Criteria

Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type 3
Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks within a minimum of 2 weeks before the Treatment Period
Participation in another interventional clinical study during the 30 days before the Treatment Period or within 5 half-lives of the final dose of the investigational product administered during the previous interventional study, whichever is longer
Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening
Currently receiving a therapy not permitted during the study
Being pregnant or breastfeeding.

Additional studies can be found at ClinicalTrials.gov