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

Launched by CSL BEHRING · Apr 17, 2023

Keywords

ClinConnect Summary

The CSL312_3003 clinical trial is studying a new treatment for children aged 2 to 11 years who have a condition called Hereditary Angioedema (HAE). This condition can cause sudden and painful swelling in different parts of the body. The trial is looking at the safety and effectiveness of a medication called CSL312, which is given as an injection under the skin to help prevent HAE attacks in kids. To participate, children need to have been diagnosed with a specific type of HAE and must have had at least two HAE attacks in the last six months.

Eligible participants can expect to receive the study medication and be monitored closely for any side effects or changes in their health. The trial is currently recruiting participants, and it's important to note that some children may not qualify if they have other types of angioedema, are using certain medications, or have specific health issues. Parents and guardians should discuss the details with their child's doctor to see if this study is a good fit for their family.

Gender

ALL

Eligibility criteria

• 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.