EUCTR2012-000083-24-DE进行中（未招募）不适用
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
- 不适用
- 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
- •1. Be =12 years of age.
- •2. 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
- •3. If currently receiving prophylactic IV CINRYZE therapy (i.e., 1000 U every 3 or 4 days or up to 2000 U per week) or other C1 INH therapy, have:
- •during the 3 consecutive months prior to randomization, an angioedema attack rate of =1.0 moderate or severe attack per month (average).
- •NOTE: if the duration of prophylactic therapy is <3 months, but at least 1 month, the subject should satisfy this attack rate (i.e., =1.0 moderate or severe attack per month [average]) for the timeframe that the subject has actually received prophylactic therapy.
- •during the 3 consecutive months prior to starting prophylactic therapy, a history of at least 2.0 moderate or severe angioedema attacks per month (average).
- •NOTE: the attack rate may be estimated based on subject recall.
- •4. If not on prophylactic C1 INH therapy, have a history of at least 2.0 moderate or severe angioedema attacks per month (average) during the 3 consecutive months prior to randomization.
- •NOTE: the attack rate may be estimated based on subject recall.
- •5. Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.
- •6. Agree to adhere to the protocol-defined schedule of assessments and procedures.
- •7. If female, be post-menopausal (cessation of menses greater than or equal to 1 year), surgically sterile, or following an acceptable nonhormonal 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.
- •8. 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.
- •9. 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.
- •To be elgible for the post treatment follow up, the subject must:
- •1.Be informed of the nature of the study and provide written informed
- •consent before any study-specific procedures are performed.
- •2.Have anti-rHuPH20 binding antibody titers detected post-baseline at a
- •titer > 1:20
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Have received any C1 INH therapy or any blood products for treatment or prevention of an angioedema attack within 7 days prior to the first dose of study drug in Treatment Period 1.
- •2. 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).
- •3. Have had angioedema attack signs or symptoms within 2 days prior to the first dose of study drug in Treatment Period 1.
- •4. Have received any androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 7 days prior to the first dose of study drug in Treatment Period 1.
- •5. 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.
- •6. Have a history of hypercoagulability (abnormal blood clotting).
- •7. Have a diagnosis of acquired angioedema or known to have C1 INH antibodies.
- •8. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any components of CINRYZE), or other blood products.
- •9. Have a known allergy to hyaluronidase or any other ingredient in the study formulation.
- •10. Be pregnant or breastfeeding.
- •11. Have received an investigational study drug within 30 days prior to the first dose of study drug in Treatment Period 1.
- •12. 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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