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A Phase II, Double-blind, Placebo-controlled, Randomized, Dose ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II)

PHVS416 (PHA-022121 soft capsules) is being developed for the treatment of HAE. The main purpose of this research study is to test the effectiveness of different doses of study drug in preventing HAE attacks. Within this study, PHVS416 will be compared to a placebo.
Hunter Smith at hsmith16@pennstatehealth.psu.edu
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05047185
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Inclusion Criteria:
Male or Female between the ages of 18 and 75 at the time of enrollement
Diagnosis of Heriditary Angioedema Type I or II
Must have had at least 3 HAE Attacks in 3 Months, or 2 HAE attacks in 2 months during screening period
Females must be willing to use highly effective contraception for the duration of the trial
Exclusion Criteria:
Diagnosis of any other chronic, recurrent angioedema
Participation in any other clinical trial in the 30 days prior to enrollment
Currently receiving any other prophylactic treatment for HAE and unwillingly to stop current medication
Infectious Diseases & Immune System, Allergies
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Location
Hershey, PA