The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
STAR-0215 will be administered as a subcutaneous injection.
Allervie Clinical Research
Birmingham, Alabama, United States
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through study completion, an average of 6 years
Change From Baseline in Monthly HAE Attack Rate
Time frame: Day 1, up to 5 years
Severity of HAE Attacks Experienced by Participants
All HAE attacks will be classified according to severity (mild, moderate, and severe).
Time frame: Day 1 through up to 5 years
Duration of HAE Attacks
Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.
Time frame: Day 1 through up to 5 years
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
Time frame: Day 1 through up to 5 years
Time to First HAE Attack After Each Dose
Time frame: Day 1 through up to 5 years
Number of HAE Attack-free Days
Time frame: Day 1 through up to 5 years
Number of Participants Experiencing Zero HAE Attacks
Time frame: Day 1 through up to 5 years
Serum Concentration of STAR-0215
Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.
Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
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Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona, United States
Acuro Research
Little Rock, Arkansas, United States
UC San Diego US HAEA Angioedema Center
San Diego, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Optimed Research
Columbus, Ohio, United States
...and 12 more locations
Plasma Levels of Cleaved High-molecular-weight Kininogen
Blood samples will be collected on dosing days to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
Number of Participants with Anti-drug Antibodies to STAR-0215
Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum.
Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years