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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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NCT03485911
Infectious Diseases & Immune System, Allergies