EUCTR2016-001651-49-SK进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicenter dose ranging study of ALX-0171 in infants and young children hospitalized for respiratory syncytial virus lower respiratory tract infection - Respire
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ablynx NV
- 入组人数
- 180
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
- •- Subject is a male or female infant or young child aged 28 days to < 2 years with gestational age = 33 weeks at screening.
- •- Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV lower respiratory tract infection.
- •- Subject has a positive RSV diagnostic test at screening.
- •- Subject is expected to have to stay in the hospital for at least 24 hours.
- •- Parent(s)/legal guardian(s) provide written informed consent in accordance with locally approved consent process at screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •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
- •- Subject is known to have significant comorbidities
- •- Subject is known to be HIV-positive (or if the child is <6 months of age, the mother is known to be HIV-positive).
- •- Subject is known to be immunocompromised.
- •- Subject has or is suspected to have an active, clinically relevant concurrent infection
- •- Subject is critically ill and/or is expected to require invasive mechanical ventilation
- •- Subject is currently participating in any other study with investigational drug or has received an investigational drug within 4 weeks or 5 half-lives of the concerned drug (whichever is longer) prior to screening
- •- Subject was previously enrolled in a clinical study of ALX-0171
研究者
相似试验
进行中（未招募）
1 期
Efficacy and safety study evaluating a new sublingual treatment in HDM allergic rhinitisHouse dust mite allergic rhinitisMedDRA version: 18.0Level: LLTClassification code 10001725Term: Allergic rhinitis due to other allergenSystem Organ Class: 100000004855EUCTR2014-004223-46-ESStallergenes S.A.990
进行中（未招募）
1 期
Study on the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by the individual patient whose kidneys are not working properly and suffering at the same time from a disease of the heart and the blood vessels and high blood sugarTreatment of cardiovascular and renal disease in patients with chronic kidney diseaseMedDRA version: 21.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2019-003297-53-ESBayer AG432
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder over 6 weeksBipolar I disorder, manic and mixed episodesEUCTR2004-000113-18-HUovartis Hungaria Kft.430
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled, multicenter phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapyDiffuse Large B-Cell LymphomaMedDRA version: 19.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-000498-40-HUovartis Pharma Services AG487
进行中（未招募）
1 期
Safety and efficacy study in patients with moderate to severe nail psoriasisModerate to severe nail psoriasisMedDRA version: 18.0Level: PTClassification code 10028703Term: Nail psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2012-005413-40-BEovartis Pharma Services AG195