An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-De… (NCT05505916) | Clinical Trial Compass
Active — Not RecruitingPhase 3
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
United States145 participantsStarted 2022-10-24
Plain-language summary
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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Confirmed diagnosis of HAE type I or II at any time in the medical history
✓. Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit.
✓. If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Enrollment Visit (except for danazol, which requires a stable dose and regimen for at least 6 months prior to the Enrollment Visit).
✓. Male or female patients 12 years of age and older.
✓. Patients must meet the contraception requirements.
✓. Patients must be able to swallow trial tablets whole.
✓. Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the eDiary.
✓. Investigator believes that the patient is willing and able to adhere to all protocol requirements.
Exclusion criteria
✕. Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety.
✕. Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator.
✕. 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.
What they're measuring
1
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.
Timeframe: 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.
2
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.
Timeframe: Throughout the duration of the trial.
3
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
✕. A clinically significant history of poor response to bradykinin receptor 2 (BR2) blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
✕. Use of attenuated androgens other than danazol (e.g., stanozolol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid) within 28 days prior to the Enrollment Visit.
✕. Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Enrollment Visit.
✕. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Enrollment Visit.
✕. Inadequate organ function, including but not limited to: