NL-OMON48423已完成2 期
A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II - KVD900-201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female adult subjects 18 years of age and older.
- •2. Confirmed diagnosis of HAE type I or II at anytime in the medical history:
- •3. At least 3 documented HAE attacks in the past 93 days, as supported by
- •medical history.
- •4. Access to and ability to use conventional attack treatment for attacks of
- •5. Adequate organ functions as defined below:
- •a. Hemoglobin within normal range;
- •b. International normalized ratio (INR)< 1.2;
- •c. Activated partial thromboplastin time (aPTT) <= upper limit of
- •normal (ULN);
- •d. Creatinine < 1x ULN;
- •e. Creatinine clearance (CrCl) >= 60 mL/min;
- •f. Alanine aminotransferase (ALT) <= 2x ULN;
- •g. Aspartate aminotransferase (AST) <= 2x ULN;
- •h. Total bilirubin <= 1.5x ULN;
- •i. Leucocytes <= 1.5x ULN;
- •j. Thrombocytes <= 1.5x ULN.
- •6. Female of childbearing potential must agree to use highly effective birth
- •control from the Screening visit until the end of the trial follow-up
- •procedures.
- •7. Females of non-childbearing potential, defined as surgically sterile (status
- •post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or
- •post-menopausal for at least 12 months, do not require contraception during the
- •8. Males with female partners of childbearing potential must agree to be
- •abstinent or else use a highly effective method of birth control as defined in
- •inclusion criterion 6 from the Screening visit until the end of the trial
- •follow-up procedures.
- •9. Provide signed informed consent and are willing and capable of complying
- •with study requirements and procedures.
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 (also known as HAE
- •type III), idiopathic angioedema, or
- •angioedema associated with urticaria.
- •2. Current use of C1INH, androgens, lanadelumab or tranexamic acid for HAE
- •prophylaxis.
- •3. Use of angiotensin-converting enzyme (ACE) inhibitors or any
- •estrogen-containing medications with systemic absorption (such as oral
- •contraceptives or hormonal replacement therapy) within
- •93 days prior to initial study treatment.
- •4. Use of androgens (e.g. stanozolol, danazol, oxandrolone,
- •methyltestosterones, testosterone) or antifibrinolytics within 30 days prior to
- •initial study treatment.
- •5. Use of lanadelumab within 10 weeks prior to initial study treatment
- •6. Use of strong CYP3A4/CYP2C9 inhibitors and inducers during participation in
- •Note: These medications include but are not limited to the following:
- •cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole, voriconazole,
- •ritonavir, boceprevir, telaprevir, troleandomycin, clarithromycin,
- •carbamazepine, enzalutamide, mitotane, phenytoin,
- •phenobarbital, fluconazole, isoniazid, metronidazole, paroxetine,
- •sulfamethoxazole, rifampicin, St. John*s Wort, diltiazem, idelalisib,
- •nefazodone and nelfinavir.
- •7. Clinically significant abnormal electrocardiogram (ECG) at Visit 1 and
- •pre-dose at Visit 2. This includes, but is not limited to, a QTcF > 470 msec
- •(for women) or > 450 msec (for men), a
- •PR > 220 msec or ventricular and/or atrial premature contractions that are more
- •frequent than occasional and/or occur as couplets or higher in grouping.
- •8. Any clinically significant history of angina, myocardial infarction,
- •syncope, clinically significant cardiac arrhythmias, left ventricular
- •hypertrophy, cardiomyopathy, or any other cardiovascular
- •abnormality.
- •9. Any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory,
- •cardiovascular) or significant disease or disorder which, in the opinion of the
- •Investigator, would jeopardize the
- •safety of the subject by taking part in the trial.
- •10. History of substance abuse or dependence that would interfere with the
- •completion of the study, as determined by the Investigator.
- •11. Known lactose allergy or intolerance.
- •12. Known hypersensitivity to KVD900 or placebo or to any of the excipients.
- •13. Participation in an interventional investigational clinical study within 93
- •days or within 5 half-lives of the last dosing of investigational drug
- •(whichever is longer) prior to initial study treatment.
- •14. Any pregnant or breast-feeding subject.
研究者
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