CSL312 for Hereditary Angioedema

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CSL Behring

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for boys and girls aged 2 to 11 with Hereditary Angioedema (HAE), weighing at least in the 10th percentile for their age. They must have had at least two HAE attacks in the past six months. Kids can't join if they're in another study, have other types of angioedema, are taking certain HAE medications, or plan to have major surgery.

Inclusion Criteria

I am between 2 and 11 years old and my weight is in the healthy range for my age.

I am either male or female.

I have been diagnosed with hereditary angioedema.

+1 more

Exclusion Criteria

I have been diagnosed with another type of swelling condition besides HAE.

I use medication to prevent swelling attacks due to HAE.

Participation in another interventional clinical study

+1 more

Participant Groups

The trial is testing CSL312 given under the skin as a preventive treatment for kids with HAE. It aims to check how safe it is, how the body processes it (pharmacokinetics/PK), and how well it works (pharmacodynamics/PD).

1Treatment groups

Experimental Treatment

Group I: CSL312Experimental Treatment1 Intervention

Ages 2-5 years and 6-11 years will have specific subcutaneous dosing schedules