Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema

Official Title

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

Keywords

Hereditary Angioedema Angioedema Angioedemas, Hereditary Antibodies, Monoclonal CSL312

Eligibility

You can join if…

Open to people ages 12 years and up

  • Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening

You CAN'T join if...

  • Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3

Locations

  • UCSD School of Medicine not yet accepting patients
    San Diego California 92122 United States
  • Raffi Tachdjian MD, Inc. accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT04656418
Phase
Phase 3
Study Type
Interventional
Last Updated