EUCTR2008-003906-32-FR进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, multi national, Phase III study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT), starting 2 months before the grass pollen season, administered as allergen based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma)
Stallergenes S.A.0 个研究点目标入组 336 人开始时间: 2008年10月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 336
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
- •Patients must meet all of the following inclusion criteria in order to participate in this study:
- •1.Written consent / assent (as applicable).
- •2.Male or female outpatients aged 12 to 65 years (inclusive).
- •3.Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
- •4.Positive SPT (wheal diameter greater than 3 mm) and grass pollen-specific IgE values of at least 0.70 kU/L.
- •5.An RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18. The RRTSS is an evaluation (by the patient) of the most severe symptoms during the previous pollen season.
- •6.Patients in general good health as determined by the medical history, physical examination (including vital signs) and safety laboratory tests.
- •7.Patients with FEV1 = 80% of the predicted value.
- •8.Female patients are eligible if they do not have child bearing potential. Female patients are considered not to have child-bearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy or bilateral oophorectomy.
- •9.Female patients of child-bearing potential are eligible if they are not sexually active or if they:
- •Use a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner), and
- •Have a negative urine pregnancy test.
- •10.Patients who are able to understand the information given, and will be compliant with the protocol including investigational product administration and visit schedules. Adult patients should also be able to complete the daily record card.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients must not meet any of the following exclusion criteria in order to participate in this study:
- •1.Positive SPT to any other seasonal allergens present during the grass pollen season including olive and cypress pollen if these allergens are endemic to the region.
- •2.Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season (for example, tree allergens).
- •3.Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
- •4.Patients with moderate or severe persistent asthma (GINA 3 or 4).
- •5.Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
- •6.Patients who have received any desensitisation treatment for grass pollen in the last 5 years.
- •7.Patients with ongoing treatment by immunotherapy with any other allergen.
- •8.Patients with any nasal or oral condition that could confound the efficacy or safety assessments such as nasal polyposis, chronic sinusitis or oral inflammation (for example oral lichen planus, oral ulceration or oral mycosis).
- •9.Patients with a known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as galactose intolerance).
- •10.Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study. These may include, but are not limited to, anaphylaxis with cardio-respiratory symptoms, chronic urticaria and angioedema, severe atopic dermatitis, malignancy, and cardiovascular, hepatic, renal, haematological, neurological, immunological and endocrine diseases.
- •11.Patients treated with systemic, nasal or inhaled corticosteroids within 4 weeks before Visit 1 or with long acting systemic corticosteroids within 12 weeks before Visit 1, whatever the indication.
- •12.Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs.
- •13.Pregnant, breastfeeding, or sexually active females who are not using a medically accepted contraceptive method as listed above.
- •14.Patients participating or having participated within 12 weeks before Visit 1 in any clinical study.
- •15.Patients who are likely to be unable to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which in the opinion of the investigator will compromise the data.
- •16.Patients with a history of drug or alcohol abuse.
- •17.Investigators, sub-investigators and study staff as well as their children or spouses and family members should not be enrolled in the study.
- •18.Patients must not be randomised in this study more than once.
研究者
相似试验
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, multi national, Phase III study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT), starting 2 months before the grass pollen season, administered as allergen based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma)Grass pollen allergic rhinoconjunctivitisMedDRA version: 9.1Level: LLTClassification code 10039085Term: Rhinitis allergicMedDRA version: 9.1Level: PTClassification code 10039085Term: Rhinitis allergicEUCTR2008-003906-32-CZStallergenes S.A.336
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RAMedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid arthritisEUCTR2006-004140-23-PTMerck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany240
进行中（未招募）
1 期
A clinical study to assess the long-term efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosison-alcoholic Steatohepatitis (NASH)MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2020-004986-38-HUInventiva S.A.1,200
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, multicentre trial to access the safety and efficacy of pre-treatment with DF01 during late pregnancy in reducing prolonged labour.Pre-treatment during late pregnancy to reduce prolonged labour.EUCTR2006-005839-20-SEDilafor AB
进行中（未招募）
不适用
A single-dose study to investigate the effects of 3 different doses of inhaled AZD2115 in COPD patientsAZD2115 is being developed to treat chronic obstructive pulmonary disease (COPD).MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-004641-41-PLAstraZeneca AB36