EUCTR2021-001226-21-NL进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Male or female patients 12 years of age and older.
- •2) Confirmed diagnosis of HAE type I or II at any time in the medical history.
- •3) Patient has access to and ability to use conventional on-demand treatment for HAE attacks.
- •4) If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must be on a stable dose and regimen for at least 3 months prior to the Screening Visit and be willing to remain on a stable dose and regimen for the duration of the trial.
- •5) Patient’s last dose of attenuated androgens was at least 28 days prior to randomization.
- •6) Patient:
- •a) has had at least 2 documented HAE attacks within 3 months prior to screening or randomization: or
- •b) is a completer of the KVD824-201 trial within 3 months prior to randomization and meets all other entry criteria to enroll in KVD900-301.
- •7) Patients must meet the contraception requirements.
- •8) Patients must be able to swallow trial tablets whole.
- •9) Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the electronic diary (eDiary).
- •10) Investigator believes that the patient is willing and able to adhere to all protocol requirements.
- •11) Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1) 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.
- •2) 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.
- •3) Use of angiotensin-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
- •4) Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
- •5) Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
- •6) Inadequate organ function, including but not limited to:
- •a) Alanine aminotransferase (ALT) >2x upper limit of normal (ULN)
- •b) Aspartate aminotransferase (AST) >2x ULN
- •c) Bilirubin direct >1.25x ULN
- •d) International normalized ratio (INR) >1.2
- •e) Clinically significant hepatic impairment defined as a Child-Pugh B or C
- •7) 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.
- •8) History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
- •9) Known hypersensitivity to KVD900 or placebo or to any of the excipients.
- •10) Prior participation in trial KVD900-201.
- •11) Participation in any gene therapy treatment or trial for HAE.
- •12) Participation in any interventional investigational clinical trial (with the exception of KVD824-201), including an investigational COVID 19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to screening.
- •13) Any pregnant or breastfeeding patient.
研究者
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