ong-term safety and efficacy of CSL312 (garadacimab) in the prophylactictreatment of hereditary angioedema attacks

Phase 1

• Conditions: Hereditary angioedema; MedDRA version: 23.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2020-003918-12-IT
• Lead Sponsor: CSL BEHRING GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Males and females aged = 12 years
2. Diagnosed with clinically confirmed C1-INH HAE
3. Experienced = 3 HAE attacks during the 3 months before Screening
4. Participated in the Run-in Period for at least 1 month (CSL312-naïve
subjects only)
5. Experienced at least an average of 1 HAE attack per month during the
Run-in Period
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Concomitant diagnosis of another form of angioedema, such as
idiopathic or acquired angioedema or recurrent angioedema associated
with urticaria
2. Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
3. Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3
months before the first day of the Run-in Period.
4. Female subjects use estrogen-containing oral contraceptives or
hormone replacement therapy within 4 weeks prior to screening
5. Female or male subjects who are fertile and sexually active not using
or not willing to use an acceptable method of contraception to avoid
pregnancy during the study and for 30 days after receipt of the last dose
of CSL312
6. Pregnant, breastfeeding, or not willing to cease breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified