EUCTR2005-002502-34-DK进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase III paediatric study of the efficacy and safety of one dose of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to children suffering from grass pollen rhinoconjunctivitis
Stallergenes S.A.0 个研究点目标入组 300 人开始时间: 2005年10月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •The inclusion criteria are to be verified at Screening (Visit 1) and reviewed at Visit 2. Patients must meet all of the following inclusion criteria in order to participate in this study:
- •1.Male or female outpatients, aged 5 to 17 years (inclusive).
- •2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- •3. Patients / parents / legal guardians who have been informed of the nature and aims of the study and have given their written consent / assent (as applicable) at Visit 1 to participate in this study in accordance with local laws and requirements
- •4. Patients / parents / legal guardians who are willing to comply with the protocol.
- •5. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
- •6. Female patients of childbearing 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 male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with vasectomised partner).
- •Note: Female patients are considered not to have childbearing potential before their menarche, or if they have had a total hysterectomy, bilateral oophorectomy or ovariectomy.
- •7. Negative urine pregnancy test on all females who have had their menarche.
- •8. Patients / parents / legal guardians who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card.
- •9. Positive SPT (wheal diameter greater than 3 mm) and IgE values greater than or equal to Class 2 for grass pollen allergens.
- •10. A score of greater than or equal to 12 on the RRTSS. (Evaluation of the most severe symptoms during the previous pollen season).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •The exclusion criteria are to be verified at Screening and reviewed at Visit 2. Patients must not meet any of the following exclusion criteria in order to participate in this study:
- •1. Allergic rhinoconjunctivitis due to a co-sensitisation likely to significantly change the symptoms of the patient throughout the study OR patients who have symptoms of rhinoconjunctivitis during the Treatment Phase due to sensitisation to allergens other than the grass pollens.
- •2. Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- •3. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included.
- •4. Patients who have taken oral steroids within 4 weeks of the Screening (Visit 1).
- •5. Patients who have received any desensitisation treatment for grass pollen.
- •6. Treatment by immunotherapy with any other allergen within the previous 5 years.
- •7. Patients at risk of non-compliance.
- •8. Participation in any clinical study during the previous 3 months.
- •9. Children of investigators, co-investigators, and of all the study collaborators should not be enrolled in the study.
- •10. Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
- •11. Patients treated with beta-blockers or under continuous corticotherapy.
- •12. Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies.
- •13. Patients with a history of drug or alcohol abuse.
- •14. Patients with fever, flu or an upper respiratory tract infection must be treated appropriately. They can be randomised after resolution of the episode.
研究者
相似试验
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 RARheumatoid arthritisEUCTR2006-004140-23-DEMerck Serono Int, a branch of Laboratoires Seron SA an affiliate of Merck KGaA, Darmstadt, Germany240
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, multi-national Phase II/III study of the safety and efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adult patients suffering from house dust mite allergic rhinitisEUCTR2007-001454-77-FRStallergenes S.A486
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, multi-national Phase II/III study of the safety and efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adult patients suffering from house dust mite allergic rhinitisEUCTR2007-001454-77-CZStallergenes S.A486
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, multi-centre, multi-national Phase II / III follow-up study to assess long-term efficacy and safety of three different dose regimens of Oralgen® Grass Pollen in patients with grass pollen related allergic rhinoconjunctivitis (follow-up study to AB0602). - NAMedDRA version: 9.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisAllergic rhinoconjunctivitisEUCTR2007-002477-31-SKArtu Biologicals Europe B.V.560
进行中（未招募）
1 期
Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)MedDRA version: 14.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersSystemic Lupus ErythematosusEUCTR2007-003698-13-GBMerck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany