EUCTR2015-005255-27-GB进行中（未招募）1 期
HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention 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 225 人开始时间: 2016年5月23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
- 225
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
入选标准
- •1. Male and female HAE subjects who are 12 years of age or older at the time of screening.
- •2. Documented diagnosis of HAE (Type I or II) based on 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 (or a prior DX-2930 study) 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 be retested if results are incongruent with clinical history or believed by the investigator to be confounded by recent LTP use. (It is understood that C1-INH therapy may alter the lab results of C1-INH assessments; therefore, the investigator's discretion in collaboration with Medical Monitor is advised for proper documentation of eligibility).
- •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. A historical baseline HAE attack rate of at least 1 attack per 12 weeks
- •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 12 to 17, whose caregiver has provided informed consent, 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 stable doses (for 3 months prior to study screening) of combined estrogen and progestin-containing hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), progestin-oral hormonal contraception associated with inhibition of ovulation, intra-uterine device (IUD, all types), or intrauterine hormone releasing systems (IUS). Notes: 1) A female whose male partner has had a vasectomy must agree to use one additional 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) are 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 the screening period through 60 days after the final study visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 21
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 yea
排除标准
- •1. Discontinued from DX-2930-03 after enrollment for any reason.
- •2. If rolling over from DX-2930-03, presence of important safety concerns that would preclude participation in this study.
- •3. 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.
- •4. Dosing with an investigational drug (not including DX-2930 or other HAE therapies) or exposure to an investigational device within 4 weeks prior to screening.
- •5. Exposure to angiotensin-converting enzyme (ACE) inhibitors within 4 weeks prior to study screening or any newly initiated or dose modification of estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) 3 months prior to the screening visit.
- •6. Unwilling to discontinue use of long-term prophylactic therapy for HAE (C1-INH, attenuated androgens, or antifibrinolytics) within 3 weeks after starting DX-2930 treatment
- •7. 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).
- •8. Pregnancy or breastfeeding.
- •9. 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, a significant pre-existing illness or other major comorbidity that the investigator considers may confound the interpretation of study results).
研究者
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