This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
KVD900 Tablet 600 mg (2 x 300 mg)
KVD900 Tablet 300 mg
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.
Time frame: AEs will be recorded from the first dose of IMP in the KVD900-302 trial up to and including the end of study (EOS) visit, a maximum of 2 years for each patient.
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.
Time frame: Throughout the duration of the trial.
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
Time frame: Throughout the duration of the trial.
Patient Global Impression of Change (PGI-C).
time to beginning of symptom relief defined as at least '' a little better'' (2 time points in a row)
Time frame: within 12 hours of initial dose of IMP administration.
Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline
Time frame: within 12 hours of initial dose of IMP administration.
PGI-S: time to HAE attack resolution
PGI-S: time to HAE attack resolution, defines as ''none''
Time frame: within 24 hours of initial dose of IMP administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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