Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary… (NCT04739059) | Clinical Trial Compass
CompletedPhase 3
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
United States171 participantsStarted 2021-04-29
Plain-language summary
This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Males and females aged ≥ 12 years
* \- Diagnosed with clinically confirmed C1-INH HAE
* \- Experienced ≥ 3 HAE attacks during the 3 months before Screening
* \- Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
* \- Experienced at least an average of 1 HAE attack per month during the Run-in Period
Exclusion Criteria:
* \- Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
* \- 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
* \- Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
* \- Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
* \- 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
* \- Pregnant, breastfeeding, or not willing to cease breastfeeding
What they're measuring
1
Number of subjects with treatment emergent adverse events (TEAEs)