EUCTR2016-001272-29-GR进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of BCX7353 as a preventative treatment to reduce the frequency of attacks in subjects with hereditary angioedema
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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 Able to provide written, informed consent
- •2 Males and non-pregnant, non-lactating females age 18 to 70 years
- •3 A clinical diagnosis of hereditary angioedema Type 1 or Type 2 as documented at any time in the medical records or at the screening visit by a low C1 INH functional level (Type 2) or a low C1 INH antigenic level (Type 1)
- •4 A documented HAE attack rate of <> HAE attacks per month for <> within the 6 months prior to the screening visit as documented in acceptable source records.
- •5 Access to and ability to use 1 or more acute medications approved by the relevant competent authority for the treatment of attacks of HAE (icatibant, plasma-derived C1 INH or recombinant C1 INH).
- •6 Female participants must meet at least 1 of the following requirements:
- •a) Be a woman of childbearing potential (defined as a nonmenopausal female who has not had a hysterectomy, bilateral oophorectomy, or documented ovarian failure) who agrees to use at least an acceptable effective contraceptive method during the study and for a duration of 30 days after last dose of study drug. One or more of the following methods are acceptable:
- •- surgical sterilization (ie, bilateral tubal occlusion or vasectomy of male partner)
- •- placement of an intrauterine device (IUD) or intrauterine system (IUS) (implanted any time prior to or during screening)
- •- progesterone-only (implantable or injectable only) hormonal contraception associated with inhibition of ovulation initiated at least 60 days prior to the screening visit
- •- male or female condom with or without spermicide
- •- occlusive cap with spermicide
- •b) Be a woman of non-childbearing potential (defined as postmenopausal for > 2 years or having a screening FSH > 40 mIU/mL if postmenopausal = 2 years or have had a hysterectomy, bilateral oophorectomy, or documented ovarian failure).
- •c) Be a woman declaring herself as either sexually abstinent or exclusively having female sexual partners. Abstinence in this study is defined as true abstinence: when this is in line with the preferred and usual lifestyle of the subject.
- •7 Male subjects must comply with the following requirements during the study and for a duration of 90 days after last dose of study drug:
- •a) Subjects with female partners of childbearing potential (defined as postmenopausal = 2 years or a non-menopausal female who has not had a hysterectomy, bilateral oophorectomy, or documented ovarian failure) must agree to utilize at least 1 acceptably effective contraceptive method. At least 1 or more of the following methods are acceptable:
- •- surgical sterilization (i.e., vasectomy or bilateral tubal occlusion of a female partner)
- •- placement of an IUD or IUS
- •- any form of hormonal contraception (oral, implantable, injectable, intravaginal, or transdermal)
- •- use of a condom with or without spermicidal foam/gel/film/cream/suppository
- •- partner’s use of an occlusive cap [diaphragm, or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository)
- •b) Male subjects who declare themselves as sexually abstinent are acceptable for the purposes of this study. Abstinence in this study is defined as true abstinence: when this is in line with the preferred and usual lifestyle of the subject.”
- •c) Male subjects who exclusively have male partners must consent to using a condom during intercourse throughout the duration of the study
- •d) Must abstain from sperm donation during the study and for a period of 90 days after last dos
排除标准
- •1 Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject’s ability to participate in the study or increases the risk to the subject of participating in the study.
- •2 Dementia, altered mental status, or any psychiatric condition, or stay in an institution further to an official or court order that would prohibit the understanding or rendering of informed consent or participation in the study.
- •3 Use of C1 INH, androgens, or tranexamic acid for prophylaxis of HAE attacks within the 7 days prior to the screening visit or initiation during the study. Androgen use is not permitted at any time during the study. Use of a C1 INH therapy for treatment of attacks is not excluded at any time.
- •4 Clinically significant abnormal ECG at the screening visit. This includes, but is not limited to, a QTcF > 470 msec, a PR > 220 msec, or ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping.
- •5 Any clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality.
- •6 Known family history of sudden death from causes other than HAE.
- •7 History of or current implanted defibrillator or pacemaker.
- •8 Any abnormal laboratory or urinalysis parameter at screening that, in the opinion of the Investigator, is clinically significant and relevant for this study. A calculated Creatinine clearance of = 60 mL/min or AST or ALT value = 2 times the upper limit of the normal reference range value obtained during screening is exclusionary.
- •9 Suspected C1INH resistance in the opinion of the Investigator and Sponsor.
- •10 History of alcohol or drug abuse within the previous year prior to the screening visit, or current evidence of substance dependence or abuse (self-reported alcoholic intake > 3 drinks/day).
- •11 Positive serology for human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •12 Pregnant, planning to become pregnant within 30 days of the study, or nursing.
- •13 Positive drugs of abuse screen (unless as used as medical treatment, e.g., with a prescription).
- •14 History of severe hypersensitivity to any medicinal product.
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