CTIS2022-502366-25-00进行中（未招募）1 期
A three-year, multi-center, double-blind, extension study to evaluate the long-term safety and efficacy of ligelizumab in patients who completed ligelizumab’s Phase III studies in food allergy - CQGE031G12303B
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
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 64（—）
- 性别
- All
入选标准
- •Signed informed consent form (ICF) and assent form (where applicable) obtained from the participant/legal representative before study participation. If a minor participant reaches the age of legal majority (as defined by local law), they must be re-consented at the next study visit, Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy (e.g., Study CQGE031G12301). Please refer to the Section 4.1 for the timing of transition., Participants who are willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge), Participants who agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout this study, Participants who are able to safely continue into the study as judged by the investigator
排除标准
- •Development of a severe or life threatening episode of an allergic reaction that required intubation and/or ICU admission during the core studies, Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core study, Development of uncontrolled asthma during the core study that could compromise the safety of the participants judged by the investigator, Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator, Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion they should not participate in this extension study, Platelets <75,000/ul at EoT of the core study
研究者
相似试验
进行中（未招募）
不适用
A 3-year, multicenter, double-blind, randomized, placebo-controlled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - 2301 E2EUCTR2007-005383-27-HUovartis Pharma Services AG500
进行中（未招募）
1 期
A 3-year, multicenter, double-blind, randomized, placebo-controlled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - 2301 E2Osteoporosis in postmenopausal womenMedDRA version: 9.1 Level: LLT Classification code 10031282 Term: OsteoporosisEUCTR2007-005383-27-GBovartis Pharma Services AG
进行中（未招募）
不适用
A 3-year, multicenter, double-blind, randomized, placebocontrolled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - NDPost menopausal osteoporosisMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausalEUCTR2007-005383-27-ITOVARTIS FARMA500
进行中（未招募）
不适用
A 3-year, multicenter, double-blind, randomized, placebo-controlled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - 2301 E2EUCTR2007-005383-27-FIovartis Pharma Services AG500
进行中（未招募）
1 期
A 3-year, multicenter, double-blind, randomized, placebo-controlled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - 2301 E2EUCTR2007-005383-27-BEovartis Pharma Services AG500