EUCTR2005-000206-31-GB进行中（未招募）1 期
A randomized, placebo-controlled, double-blind Phase III study of the efficacy and safety of recombinant human C1 inhibitor for the treatment of acute attacks in patients with hereditary angioedema. - Phase III study of recombinant human C1 inhibitor
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
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
- •Aged at least 16 years
- •Signed written informed consent
- •Clear clinical and laboratory diagnosis of HAE with baseline plasma level of functional C1INH of less than 50 % of normal.
- •Open-label treatment
- •Above criteria
- •Evidence for exacerbation or development of an abdominal attack and/or of facial-oro-pharyngeal angioedema and/or laryngeal angioedema and/or of genito-urinary angioedema and/or peripheral angioedema. Patients must notify and discuss symptoms with the investigator prior to travelling to the study centre.
- •Onset of eligible symptoms not longer than 5 h ago.
- •Patient’s VAS score of overall severity of angioedema symptoms at least at one location at the time of evaluation ( t = - 1 h) of at least 50 mm, where 0 mm means ‘no symptoms at all’ and 100 mm means ‘extremely disabling’. This inclusion criterion is set to allow suffcient room for improvement in response to study medication.
- •No clear regression of angioedema signs by VAS at t = 0 h; just prior to the administration of study medication. Thus, no beginning of relief by VAS at t = 0 h (reduction of 20 mm or more) compared with VAS score at determination of eligibility, t = - 1 h.
- •Above screening and treatment criteria continue to be met for subsequent eligible
- •Day 22 post-randomized treatment follow-up visit has occurred.
- •Minimum interval of 22 Days between subsequent open-label treatments
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A history of administration of pharmaceuticals derived from rabbits (e g. antisera, rhC1INH) in conjunction with any evidence of a relation with allergic reactions.
- •A history of anaphylaxis, or severe allergies (i.e. requiring medication) to food, proteins and/or drugs.
- •A history of allergic reactions to C1INH concentrates or rabbit protein.
- •A diagnosis of acquired C1INH deficiency (exclude patients with AAE).
- •Pregnancy, breast-feeding or current intention to become pregnant.
- •Known or suspected addiction to narcotics.
- •Blood donation in the past 3 months.
- •Participation in another clinical study in the past 3 months or participation in two or more clinical studies prior to this study in the last 12 months.
- •Any clinically significant abnormality in the routine hematology, biochemistry and urinalysis.
- •Any condition or treatment that in the opinion of the investigator might interfere with the evaluation of the study objectives.
- •Open-label treatment
- •Above criteria; no (expected) clinically significant abnormalities in routine laboratory analyses.
- •Patients presenting or developing a life-threatening attack (an attack requiring immediate emergency procedures to prevent death, hypoxemia related injuries or other unfavorable outcomes).
- •Any reported SAE related to (randomized or open-label) study drug administration.
- •Any changes since screening and/or the moment of diagnosis of the present eligible
- •attack that would exclude subject based on above exclusion criteria.
- •Patients presenting or developing a life-threatening attack (an attack requiring
- •immediate emergency procedures to prevent death, hypoxemia related injuries or
- •other unfavorable outcomes).
研究者
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