EUCTR2011-004254-25-DE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, multicenter, 28-week treatment study with an 8 week follow-up period to investigate the impact of subcutaneous Omalizumab on quality of life measures as well as the incidence and severity of angioedema in patients with chronic spontaneous urticaria having a history of angioedema despite H1-antihistamine therapy - X-ACT
ovartis Pharma GmbH0 个研究点开始时间: 2012年3月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Patient is informed about study procedures and medications and has given written informed consent before any assessment.
- •2.Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
- •3.Male or Female of any race aged 18-75 years
- •4.Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1 antihistamines at Baseline (Day -14) based on patient’s medical history, as defined by all of the following:
- •The presence of itch and hives for > 6 weeks
- •UAS7 score (range 0-42) = 14
- •5.Patient has a history of insufficient response to 4x of the approved dose of nsH1-antihistamines.
- •6.Patients on high dose nsH1-antihistamine (2-4x of the approved dose) for at least 3 consecutive days immediately prior to the Day -14 screening visit (current use must be documented on the day of screening visit).
- •7.CU-Q2oL Score = 30 at baseline
- •8.CSU diagnosis for = 6 months
- •9.CSU with occurrence of angioedema at least 4x in the last 6 months
- •Are the trial subjects under 18? no
- •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
- •1.Patients with non urticaria associated angioedema
- •2.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of the compound, whichever is longer
- •3.History of hypersensitivity to any of the study drugs (omalizumab) or rescue medication or to drugs of similar chemical structures.
- •4.Evidence of parasitic infection.
- •5.Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch.
- •6.Previous treatment with omalizumab within 6 months prior to screening.
- •7.Treatment with defined comedications
- •8.History of anaphylactic shock.
- •9.Presence of clinically significant cardiovascular, bronchial, neurological, psychiatric, metabolic or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients.
- •10.Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions.
- •11.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •12.Women who are pregnant or breast feeding or capable of becoming pregnant and not practicing a medically approved method of contraception1.
- •15.Permanent severe diseases, especially those affecting the immune system, except CSU.
- •16.Presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).
- •17.History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
- •18.History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
- •19.Evidence of severe renal dysfunction.
- •20.Evidence of significant hepatic disease.
- •21.Patient considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits.
- •22.Serious psychiatric and/or psychological disturbances.
- •23.History of drug or alcohol abuse.
- •24.Patient unable to complete a patient diary or complete questionnaires on paper.
- •25.Any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule.
- •12.26.Patients, who have already been randomized into this trial earlier must not be included a second time.
- •13.27.Study personnel or first degree relatives of investigator(s) must not be included in the study.
研究者
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