2023-505904-41-00招募中3 期
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 A Pharmacokinetic Subtrial in Adolescent Patients with Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 25
- 主要终点
- Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AEs, and AEs causing premature discontinuation
研究概览
简要总结
To assess the safety of long-term administration of KVD900 in adolescent and adult patients with HAE type I or II.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients may roll over from KVD900-
- •Patient provides signed informed consent or assent (when applicable). A parent or LAR must also provide signed informed consent when required.
- •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
- •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.
排除标准
- •Discontinued from the KVD900-301 trial for reasons of non-compliance, withdrawal of consent, or safety.
- •History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
- •Known hypersensitivity to KVD900 or to any of the excipients.
- •Participation in any gene therapy treatment or trial for HAE.
- •Participation in any interventional investigational clinical trial, including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to the Enrollment Visit.
- •Any pregnant or breastfeeding patient.
- •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.
- •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 (e.g., stanozolol, danazol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamic acid) within 28 days prior to the Enrollment Visit.
- •Use of 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: a) Alanine aminotransferase (ALT) >2x ULN b) Aspartate aminotransferase (AST) >2x ULN c) Bilirubin direct >1.25x ULN d) INR >1.2 e) Clinically significant hepatic impairment defined as a Child-Pugh B or C
- •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.
结局指标
主要结局
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AEs, and AEs causing premature discontinuation
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AEs, and AEs causing premature discontinuation
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
次要结局
- PGI-C: time to beginning of symptom relief defined as at least '' a little better'' (2 time points in a row) within 12 hours of initial dose of IMP administration.
- PGI-S: time to first incidence of 2 time points in a row decrease from baseline within 12 hours of initial dose of IMP administration.
- PGI-S: time to HAE attack resolution defined as ''none'' within 24 hours of initial dose of IMP administration.
研究者
KalVista Clinical
Scientific
Kalvista Pharmaceuticals Limited
研究点 (25)
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