EUCTR2015-003943-20-DE进行中（未招募）1 期
HELP Study™: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX 2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
Dyax Corp., an indirect, wholly-owned subsidiary of Shire plc.0 个研究点目标入组 120 人开始时间: 2015年12月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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. Males and females 12 years of age or older at the time of screening
- •2. Documented diagnosis of HAE (Type I or II) based upon all of the following :
- •- Documented clinical history consistent with HAE (subcutaneous or mucosal nonpruritic swelling episodes without accompanying urticaria)
- •- Diagnostic testing results obtained during screening that confirm HAE Type I or II :
- •C1 inhibitor (C1-INH) functional level < 40% of the normal level. Subjects with functional C1-INH level 40-50% of the normal level may be enrolled if they also have a C4 level below the normal range.
- •Subjects may begin participating in the run-in period before these diagnostic results are available.
- •Subjects may be retested if results are incongruent with clinical history or believed by the Investigator to be confounded by recent LTP use.
- •- At least one of the following : age at reported onset of first angioedema symptoms = 30 years, a family history consistent with HAE Type I or II, or C1q within normal range.
- •3. Experiencing a baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks as confirmed during the run-in period.
- •4. Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form. Subjects age to 12 to 17, whose caregiver provides informed consent, and are willing and able to read, understand and sign an assent form.
- •5. Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study as follows:
- •- Females of childbearing potential must agree to be abstinent or it is recommended to use highly effective forms of contraception from screening through 30 days after the final study visit. This includes progestin-only oral contraceptive associated with inhibition of ovulation (oral, injectable, or implantable), intra-uterine device (IUD, all types) or intrauterine hormone releasing system (IUS). Notes: 1) A female whose male partner has had a vasectomy must agree to use one additionnal form of medically acceptable contraception. 2) Use of a male condom with or without spermicide or cervical cap, diaphragm or sponge with spermicide or a combination (double-barrier methods) is not considered highly effective.
- •- 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 study.
- •- Males, including males who are surgically sterile (post vasectomy), with female partners of childbearing potential must agree to be abstinent or else use a medically acceptable form of contraception from screening through 60 days after the final study visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 103
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema (AAE), HAE with normal C1-INH (also known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria.
- •2. Participation in a prior DX-2930 study.
- •3. Dosing with an investigational drug or exposure to an investigational device within 4 weeks prior to screening.
- •4. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks prior to screening.
- •5. Exposure to androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 2 weeks prior to entering the run-in period.
- •6. Use of long-term prophylaxis for HAE (C1-INH, attenuated androgens, anti-fibrinolytics) within 2 weeks prior to entering the run-in period.
- •7. Use of short-term prophylaxis for HAE within 7 days prior to entering the run-in period. Short-term prophylaxis is defined as C1-INH, attenuated androgens, or anti-fibrinolytics used to avoid angioedema complications from medically indicated procedures.
- •8. Any of the following liver function test abnormalities : alanine aminotransferase (ALT) > 3x upper limit of normal, or aspartate aminotransferase (AST) >3x upper limit of normal, or total bilirubin > 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's Syndrome).
- •9. Pregnancy or breastfeeding.
- •10. Subject has any condition that, in the opinion of the Investigator or Sponsor, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results (e.g. history of substance abuse or dependence, significant pre-existing illness or other major comorbidity that the Investigator considers may confound the interpretation of study results).
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