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A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects with Hereditary Angioedema

This study is for patients diagnosed with Type 1 or Type 2 Hereditary Angioedema (HAE) and have suffered HAE attacks (episodes of swelling), and are either not using HAE medications to prevent HAE attacks or for medical or personal choice reasons have decided to discontinue using these medications. This research is being done to compare the effects of two different doses of BCX7353 compared to placebo. Placebo-containing capsules look exactly like BCX7353 capsules, but do not contain BCX7353 or any other drug. The Sponsor will test two different doses of BCX7353 to see if BCX7353 is able to prevent or reduce the number of swelling episodes or attacks in people with HAE when taken every day by mouth, compared to placebo. This research study will also assess the safety of the new drug BCX7353.
Terri Smith at tjs97@psu.edu or 717-531-4513
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This study is NOT accepting healthy volunteers
NCT03485911
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Inclusion Criteria:
Adults & Children 12 years or older
Diagnoses with HAE Type 1 or Type 2
2 or more HAE attacks per month
Exclusion Criteria:
Pregnant females or planning on becoming pregnant or nursing
Anticipated use of short-term prophylaxis for pre-planned procedure or surgery
Chest pain, heart attack, passing out or significant heart beat abnormality
Pacemaker or defibrillator implanted
Family history of sudden cardiac death not related to HAE
Infectious Diseases & Immune System, Allergies
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Location
Hershey, PA