A study to investigate CSL312 in subjects with hereditary angioedema(HAE)

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: EUCTR2018-000605-24-DE
• Lead Sponsor: CSL Behring LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-28
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Male or female
- Aged = 18 to = 65 years
- A diagnosis of C1-INH HAE or FXII/PLG HAE;
- For subjects with C1-INH HAE: = 4 HAE attacks over a consecutive 2-
month period during the 3 months before Screening, as documented in
the subject's medical record.
Are the trial subjects under 18? no
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of clinically significant arterial or venous thrombosis, or current
clinically significant prothrombotic risk
- History of an uncontrolled, abnormal bleeding event due to a
coagulopathy, or a current clinically significant coagulopathy or clinically
significant risks for bleeding events
- Known incurable malignancies

Study & Design

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