EUCTR2021-001176-42-NL进行中（未招募）1 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 - KONFIDENT-S
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients may roll over from KVD900-301.
- •1) Confirmed diagnosis of HAE type I or II at any time in the medical history
- •2) Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit.
- •3) 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.
- •4) Male or female patients 12 years of age and older.
- •5) Patients must meet the contraception requirements.
- •6) Patients must be able to swallow trial tablets whole.
- •7) 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.
- •8) Investigator believes that the patient is willing and able to adhere to all protocol requirements.
- •9) Patient provides signed informed consent or assent (when applicable). A parent or LAR must also provide signed informed consent when required.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 134
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1) Discontinued from the KVD900-301 trial for reasons of non-compliance, withdrawal of consent, or safety.
- •2) Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator.
- •3) 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.
- •4) 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.
- •5) 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.
- •6) Use of ACE inhibitors within 7 days prior to the Enrollment Visit.
- •7) 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.
- •8) 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
- •9) 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.
- •10) History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
- •11) Known hypersensitivity to KVD900 or to any of the excipients.
- •12) Participation in any gene therapy treatment or trial for HAE.
- •13) 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.
- •14) Any pregnant or breastfeeding patient.
研究者
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