NL-OMON51973已完成2 期
oral PHA-022121 for the acute treatment and prophylaxis Of angioedema attacks in Patients with Acquired C1-Inhibitor Deficiency - POP-AID
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
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 64（—）
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.
排除标准
- •Patients who meet any of the following criteria will be excluded from the
- •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
- •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)
- •Patients who meet all in- and exclusion criteria but are unable to adhere to
- •the diary and unforeseen visit requirements of part 1 as determined by the
- •investigator, may participate in part 2 only.
研究者
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