A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
Status: | Recruiting |
---|---|
Conditions: | Skin and Soft Tissue Infections |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/6/2019 |
Start Date: | October 29, 2018 |
End Date: | September 2020 |
Contact: | Trial Registration Coordinator |
Email: | clinicaltrials@cslbehring.com |
Phone: | 610.878.4000 |
A Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema
This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to
investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to
prevent attacks in subjects with HAE.
investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to
prevent attacks in subjects with HAE.
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.
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
We found this trial at
11
sites
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