CTIS2023-503958-12-00进行中（未招募）1 期
Prospective, open-label study to analyze the efficacy and safety of low-dose oral immunotherapy in children with severe IgE-mediated cow's milk allergy treated with omalizumab. ILO study.
Hospital Infantil Universitario Nino Jesus0 个研究点目标入组 20 人开始时间: 2023年6月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •1. Men and women between the ages of 6 and 15 at the time of signing the consent/assent. 2. Signature of informed consent and/or assent (where applicable), which must be obtained prior to participation in the study. Parents/legal guardians and participants ages 12-15 must be able to understand and provide written consent and assent, respectively. 3. Documented medical history of allergy to milk or foods containing milk. 4. Episodes of anaphylaxis due to ingestion of cow's milk (> 0) and/or the diagnosis of asthma. 5. Serum IgE to cow's milk and casein > 49 kUA/L at Screening Visit 1. 6. Positive skin tests for cow's milk and casein. It is defined as a mean wheal diameter (mean of the sum of the largest and smallest diameters) > 3 mm compared to the negative control. 7. Participants must weigh > 19 kg at Screening Visit 1. 8. Participants must be able to receive injections (study drug), perform oral challenge testing, and must continue to be exposed to cow's milk throughout the study.
排除标准
- •1. Use of other investigational drugs within 5 half-lives or 30 days prior to Screening Visit 1 (whichever is longer). 2. History of allergy to omalizumab or its excipients. 3. Allergy to any of the components of the matrix used for the double-blind placebo-controlled oral challenge trial (PODCCP) with milk. 4. Inability to complete study procedures and follow-up. 5. Subjects having a combination of weight and IgE that requires Omalizumab doses greater than 1,200 mg/4 weeks. 6. History of life-threatening allergic reaction after ingestion of milk that required admission to the Intensive Care Unit in the 60 days prior to the Screening Visit. 7. Participants with uncontrolled asthma (according to GINA, GINA 2022 guidelines) who meet any of the following criteria: a. FEV1 < 80% predicted at Screening Visit 1. b. One hospitalization for asthma in the 12 months prior to Screening Visit 1. 8. Patients with severe persistent asthma who require continued treatment with omalizumab. 9. History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, symptoms of dysphagia (eg, difficulty swallowing), recurrent gastrointestinal symptoms of undiagnosed etiology, or meeting clinical criteria for cow's milk protein-induced enterocolitis (FPIES) . 10. Current or past history of mast cell disorders, including mastocytosis. 11. Use of prohibited medication or medication not permitted under certain conditions. 12. Participants with evidence of parasitic helminthic infestation to a pathogenic organism evidenced by stool study at Screening Visit 1. 13. History of malignancy in the previous 5 years. 14. Clinically significant cardiovascular diseases. 15. Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or calcium channel blockers. 16. Neurological, psychiatric or metabolic diseases that may interfere or compromise the safety of patients or the evaluation, interpretation of study results or prevent completion of the study. 17. History of, or current treatment for, liver disease or serum transaminase levels 1.5 times the upper limit of normal at Screening Visit 1. 18. History of renal disease or serum creatinine levels 1.5 times the upper limit of normal at Screening Visit 1. 19. Platelets < 100,000/µL at Screening Visit 1. 20. Current participation in any other intervention study. 21. Subject is in dose escalation (dose escalation) phase of immunotherapy for another allergen (has not reached maintenance dose). 22. Pregnancy or lactation.
研究者
相似试验
招募中
1 期
Open-label, prospective study evaluating the efficacy and safety of Tirbanibulin 1% (Klisyri®) in the treatment of superficial basal cell carcinomaCTIS2023-505971-66-00Centre Hospitalier Universitaire De Nice55
招募中
不适用
Prospective study to assess the efficacy and safety of different doses of antihistamines in treating chronic spontaneous urticariaCTRI/2016/07/007099All India Institute of Medical Sciences96
招募中
2 期
An Open labeled study in efficacy of add-on Ayurveda intervention in comparison with standard in Covid-19 patients with moderate severity and with type 2 diabetes followed by 60 day follwo-upCTRI/2020/12/029985AVP Research Foundation
招募中
3 期
Dizester a Herbal formulation for dyspepsiaCTRI/2021/09/036266Dr Willmar Schwabe India Pvt Ltd
已完成
不适用
This is a single center study wherein the efficacy and safety of Saberry capsules will be studied in adult male or female patients suffering from Non-Alcoholic Fatty Liver Disease.CTRI/2016/04/006847Sami Labs Limited24