NL-OMON51499招募中2 期
Oral ONCE Daily prophylaxis with PHA-022121 in Patients with Acquired C1-Inhibitor Deficiency - ONCE-AID
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
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
- •- Provision of signed and dated informed consent form - Male or female, aged >=
- •35 at enrolment - Diagnosis of AAE-C1-INH based upon all of the following: 1.
- •Documented clinical history consistent with AAE-C1-INH (subcutaneous or
- •mucosal, nonpruritic swellings without accompanying urticaria 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 four months, or at
- •least two angioedema attacks in the last two months. For patients that
- •previously participated in POP-AID part 2, a historical attack-rate of at least
- •three attacks in four months or two attacks in two months previous to the start
- •of POP-AID part 2 is required • Reliable access to and experience with using
- •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 enrolment 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 two weeks after each
- •administration of study drug. In addition, they must agree to not donate sperm
- •during study participation.
排除标准
- •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 >
- •three drinks/day) • History of documented severe hypersensitivity to any
- •medicinal product • Participation in any investigational drug study within five
- •half-lives of study drug at enrolment • 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
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