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An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II

KONFIDENT-S is a trial to evaluate the long-term safety of KVD900 in patients who are 12 years of age or older with HAE type I or II. This trial will be conducted on an outpatient basis and includes in-clinic visits and televisits. The study will have multiple centers that will be participating in the study. Subjects will receive the study drug as this study does not include a placebo drug.

There will be 10 in-person visits and 14 televisits. Blood will be drawn at all of the in-person visits. The patient will need to complete a daily diary, and complete electronic questionnaires.

Timothy Craig
Kristina Richwine - at or 717-531-4506

This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Confirmed diagnosis of Type 1 or 2 HAE
Have had at least 2 documented HAE attacks within 3 months prior to the enrollment visit.
Must have been on a stable dose and regimen with one of the protocol-allowed therapies for long-term prophylactic treatment for at least 6 months prior to the enrollment visit.
Male or Female
Must be 12 years of age and older.

Exclusion Criteria:
Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1-inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
Use of attenuated androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g. tranexamic acid) within 28 days prior to the Enrollment Visit.
Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial.
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
Any pregnant or breastfeeding patient.
Not applicable
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Location Contacts
Hershey, PA ,