KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
KVD900 Tablet 150 mg (2 x 75 mg)
KVD900 Tablet 300 mg (1 x 300 mg)
KVD900 Tablet 600 mg (2 x 300 mg)
KalVista Investigative Site
Birmingham, Alabama, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) that met any of the following conditions: (1) began on or after the first dose of IMP, (2) began before the first dose of IMP and increased in severity on or after first dose, (3) was completely missing a start date and the stop date, (4) was completely missing a start date and the stop date was on or after the first dose of IMP. An on-treatment TEAE was defined as any TEAE occurring within 3 days of IMP administration. A treatment-related TEAE was an AE considered related to the IMP by the investigator. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation, resulted in significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event (based upon medical and scientific judgment).
Time frame: From first dose of IMP until the Final/Early Termination (ET) Visit, up to a maximum of 54 weeks.
Plasma Concentrations of Sebetralstat
During the Enrollment Visit, participants were dosed with IMP (sebetralstat 300 mg ED) and monitored for tolerability. Pharmacokinetic (PK) samples were collected via venous access or capillary collection (eg, finger prick) at specified timepoints. For participants enrolled under protocol v3.4 who received sebetralstat 600 mg ED, a second PK assessment was performed at the Dose Increase Visit. The Dose Increase Visit occurred as soon as possible after implementation of the protocol amendment and could occur at any time during the participant's participation in the trial.
Time frame: At 0.5 hours (±5 min), 2 hours (±15 min), and 4 hours (±15 min) post-dose. PK assessments for sebetralstat 300 mg ED were conducted at the Enrollment Visit, and for 600 mg ED at the Dose Increase Visit (up to 12.6 months after Enrollment Visit).
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KalVista Investigative Site
Scottsdale, Arizona, United States
KalVista Investigative Site
San Diego, California, United States
KalVista Investigative Site
Santa Monica, California, United States
KalVista Investigative Site
Evansville, Indiana, United States
KalVista Investigative Site
Wheaton, Maryland, United States
KalVista Investigative Site
St Louis, Missouri, United States
KalVista Investigative Site
Toledo, Ohio, United States
KalVista Investigative Site
Hershey, Pennsylvania, United States
KalVista Investigative Site
Dallas, Texas, United States
...and 14 more locations