EUCTR2015-002478-19-ES进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 U of C1 Esterase Inhibitor [Human] Liquid for Injection 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
- 66
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 diagnosis of HAE (Type I or II) and a functional C1 INH level less than 50% of normal.
- •3. Meet one of the following criteria (attack rate may be based on subject recall in conjunction with the subject's medical records):
- •a. If subject is adult (>18 years of age) and currently receiving prophylactic therapy with C1 INH, have a history of ?2.0 angioedema attacks per month (average) during the 3 consecutive months prior to starting prevention therapy.
- •b. If subject is adolescent (>12 and <18 years of age) or adult and not receiving
- •prophylactic therapy with C1 INH, have a history of ?2.0 angioedema attacks
- •per month (average) during the 3 consecutive months prior to the screening
- •c. If subject is adult (>18 years of age) and currently receiving a stable dose of
- •attenuated androgens, have a history of ?2.0 angioedema attacks per month
- •(average) during the 3 consecutive months prior to the screening visit.
- •4. For subjects ?18 years of age, be willing to receive treatment with icatibant for any angioedema attacks that occur during the study that, in the opinion of the healthcare care provider, require medical intervention. Note: For subjects >12 to <18 years of age, standard of care therapy per local protocols should be provided.
- •5. Agree to adhere to the protocol-defined schedule of assessments.
- •6. If female, must have a negative serum beta human chorionic gonadotrophin (ß-hCG) pregnancy test at the screening visit and must have a negative urine pregnancy test prior to the first dose of investigational product (Visit 1a), and agree to comply with any applicable contraceptive requirements of the protocol.
- •7. If male, be surgically sterile or agree to follow an acceptable method of birth control (eg, abstinence, barrier control) from the screening visit through 2 months after the last dose of investigational product.
- •8. 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.
- •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/Independent Reviewing Authorities 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: 16
- •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 17
排除标准
- •1. Adults (>18 years of age) receiving prophylactic IV CINRYZE that exceeds the approved dosing regimen of 1000 U every 3 or 4 days (receiving a weekly dose >2000 U).
- •2. Adolescents (>12 and <18 years of age) currently receiving prophylactic therapy with C1 INH.
- •3. Have had signs or symptoms of an angioedema attack within 2 days prior to the first dose of the investigational product in Treatment Period 1.
- •4. Have received any C1 INH therapy or any blood product for the treatment or prevention of angioedema attacks within 3 calendar days prior to the first dose of investigational product in Treatment Period 1.
- •5. If female, have started or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progestin containing products) within 2 months prior to the screening visit.
- •6. Have a history of hypercoagulability (abnormal blood clotting) or other predisposition for thromboembolism.
- •7. Have a diagnosis of acquired angioedema or known presence of anti-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. Be pregnant or breastfeeding.
- •10. Have received an investigational drug within 30 days prior to the first dose of
- •investigational product in Treatment Period 1.
- •11. 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 investigational product or interpretation of study results.
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