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.

13 Sites

20 Participants

ACTIVE NOT RECRUITING

2 Years to 11 Years

If interested, contact clinicaltrials@cslbehring.com or +1 610-878-4697 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

PennState Health Milton S. Hershey Medical Center

Hershey,Pennsylvania,United States,17033

AARA Research Center

Dallas,Texas,United States,75231

Campbelltown Hospital, Western Sydney University

Campbelltown,Texas,Australia,NSW2560

Ottawa Allergy Research Corp

Ottawa,Texas,Canada,K1H1E4

HZRM Hmophilie Zentrum Rhein Main GmbH

Frankfurt am Main,Hesse,Germany,60596

Charit Universittsmedizin Berlin

Berlin,Hesse,Germany,12203

Universittsklinikum Frankfurt

Frankfurt am Main,Hesse,Germany,60590

Barzilai University Medical Center

Ashkelon,Hesse,Israel,7830604

Inclusion Criteria

1. Male or female
2. Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age
3. Diagnosed with clinically confirmed C1-INH HAE
4. Experienced ≥ 2 HAE attacks during the 6 months before Screening

Exclusion Criteria

1. Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type 3
2. 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
3. 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
4. Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening
5. Currently receiving a therapy not permitted during the study
6. Being pregnant or breastfeeding.

Additional studies can be found at ClinicalTrials.gov