EUCTR2021-000720-36-NL进行中（未招募）1 期
oral PHA-022121 for the acute treatment and prophylaxis Of angioedema attacks in Patients with Acquired C1-Inhibitor Deficiency - POP-AID
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3
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
- •In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Male or female, aged > 35 at enrollment
- •Diagnosis of AAE-C1-INH based upon all of the following:
- •1.Documented clinical history consistent with AAE-C1-INH (subcutaneous or mucosal, nonpruritic swelling without accompanying urticarial and C1-INH activity < 0.63mE/L)
- •2.At least one of the following:
- •Age at reported onset of first angioedema symptoms = 40 years AND family history negative for angioedema
- •C1q below lower limit of normal (88 kU/L) AND absence of SERPING1 mutation
- •Serological confirmation of antibodies against C1-INH
- •Documented history of at least three angioedema attacks in the last 4 months, or at least two angioedema attacks in the last 2 months.
- •Reliable access and experience to use icatibant to effectively manage acute angioedema attacks
- •Female patients of childbearing potential must agree to be abstinent or to use highly effective forms of contraception methods from enrollment through the end of the study. This includes progestin-only oral contraceptive associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device (IUD, all types) or intrauterine hormone releasing systems (IUS). A female of childbearing potential whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.
- •Male patients, including males who are surgically sterile (post vasectomy), who have a female partner of childbearing potential must agree to be sexually abstinent or use a medically acceptable form of barrier contraception for 2 weeks after each administration of study drug. In addition, they must agree to not donate sperm during study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Patients who meet any of the following criteria will be excluded from the study:
- •Pregnancy or breast-feeding
- •Clinically significant abnormal ECG, most notably a QTcF > 470 ms (for females) or > 450 ms (for males)
- •Any clinically significant history of angina, myocardial infarction, syncope, stroke, left ventricular hypertrophy or cardiomyopathy, or any other cardiovascular abnormality within the previous year
- •Any other systemic disease (e.g., gastrointestinal, renal, respiratory, neurological) or significant disease or disorder that would interfere with the patient’s safety or ability to participate in the study
- •Active infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •History of abnormal hepatic function (AST > 2×ULN, ALT > 2×ULN, or total bilirubin > 1.5×ULN)
- •History of abnormal renal function (eGFR CKD-EPI < 60 mL/min/1.73 m2)
- •History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse (self-reported alcoholic intake > 3 drinks/day)
- •History of documented severe hypersensitivity to any medicinal product
- •Participation in any other investigational drug study currently, within the last 30 days or within 5 half-lives of study drug at enrollment (whichever was longer)
- •Regular use of corticosteroids, antihistamines, narcotics, and other pain relief medications for acute angioedema attack treatment
- •Use of concomitant medication that are moderate or potent inhibitors/inducers of CYP3A4 or are metabolized by CYP3A4 and have a narrow therapeutic range, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit as well as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids (not for topical use or inhalation)
研究者
相似试验
已完成
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oral PHA-022121 for the acute treatment and prophylaxis Of angioedema attacks in Patients with Acquired C1-Inhibitor DeficiencyNL-OMON51973Academisch Medisch Centrum6
尚未招募
不适用
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