EUCTR2012-000083-24-ES进行中（未招募）1 期
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, DOSERANGING, CROSSOVER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF CINRYZE® (C1 ESTERASE INHIBITOR [HUMAN]) WITH RECOMBINANT HUMAN HYALURONIDASE (rHuPH20) FOR THE PREVENTION OF ANGIOEDEMA ATTACKS IN ADOLESCENTS AND ADULTS WITH HEREDITARY ANGIOEDEMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
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
- •To be eligible for this protocol, a subject must:
- •Be >=12 years of age.
- •Have a confirmed diagnosis of HAE with a history of at least one of the following:
- •C1 INH antigen level below normal; Functional C1 INH level below normal; If currently receiving prophylactic IV CINRYZE therapy (i.e., 1000 U every 3 or days or up to 2000 U per week), have: during the 3 consecutive months prior to randomization, an HAE attack rate of <=1.0 moderate or severe attack per month (average). During the 3 consecutive months prior to starting prophylactic IV CINRYZE therapy, a history of at least 2.0 moderate or severe HAE attacks per month (average).
- •If not on prophylactic IV CINRYZE therapy, have a history of at least 2.0
- •moderate or severe HAE attacks per month (average) during the 3 consecutive
- •months prior to randomization.
- •Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.
- •Agree to adhere to the protocol-defined schedule of assessments and procedures. If female, be post-menopausal (cessation of menses greater than or equal to 1 year), surgically sterile, or following an acceptable non-hormonal method of birth control such as intrauterine device or barrier control for at least 1 complete menstrual cycle before the screening visit and agree to continue use through the 30-day post-treatment visit, or using hormonal birth control products for at least 3 months prior to the first dose of study drug in Treatment Period 1 and agree to continue use through the 30-day post-treatment visit. If male, be surgically sterile or agree to follow an acceptable method of birth control (e.g., barrier control) from the screening visit through 2 months after the last dose of study drug. If an adult (>=18 years of age), be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
- •If a child (<18 years of age), have a parent(s)/legal guardian who is informed of the nature of the study provide written informed consent for the child to participate in the study before any study-specific procedures are performed (with assent from the child when appropriate). Alternatively, certain sites/IRAs may permit adolescents who are <18 years of age to be informed of the nature of the study and provide written informed consent without consent from a parent(s)/legal guardian.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •To be eligible for this protocol, a subject must not:
- •Have received any C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 7 days prior to the first dose of study drug in Treatment Period 1.
- •Be receiving prophylactic IV CINRYZE that exceeds the approved dosing regimen of 1000 U every 3 or 4 days (maximum weekly dose of 2000 U).
- •Have had HAE attack signs or symptoms within 2 days prior to the first dose of study drug in Treatment Period 1.
- •Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug in Treatment Period 1.
- •If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug in Treatment Period 1.
- •Have a history of hypercoagulability (abnormal blood clotting).
- •Have a history of allergic reaction to C1 INH products, including CINRYZE (or any components of CINRYZE), or other blood products.
- •Have a known allergy to hyaluronidase or any other ingredient in the study formulation.
- •Be pregnant or breastfeeding.
- •Have received an investigational study drug within 30 days prior to the first dose of study drug in Treatment Period 1.
- •Have, as determined by the Investigator and/or the Sponsor?s medical monitor, any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results.
研究者
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