CTIS2022-502386-13-00招募中1 期
A Phase 3 Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema in Pediatric Subjects 2 to 11 Years of Age - CSL312_3003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- •Male or female, Aged 2 to 11 years, inclusive, with body weight = 10th percentile based on age, Diagnosed with clinically confirmed C1-INH HAE, Experienced = 2 HAE attacks during the 6 months before Screening
排除标准
- •Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type III, Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks, Participation in another interventional clinical study, Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening, Currently receiving a therapy not permitted during the study, Being pregnant or breastfeeding
研究者
相似试验
进行中（未招募）
不适用
Primary vaccination course with the pneumococcal vaccine GSK 1024850A, in healthy infants in Vietnam when co-administered with GSK Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine.Healthy volunteers (for three-dose primary vaccination against Streptococcus pneumoniae in healthy infants between 6 to 12 weeks of age at the time of the first vaccination)MedDRA version: 18.0Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862EUCTR2012-000162-38-Outside-EU/EEAGlaxoSmithKline Biologicals300
进行中（未招募）
不适用
A phase III open label study to evaluate safety and efficacy of Boceprevir-response guided therapy in controlled HIV patients with chronic hepatitis C genotype 1 infection who failed previously to Peginterferon /ribavirin.HCV and HIV seropositive coinfectionMedDRA version: 14.1Level: LLTClassification code 10065949Term: HCV coinfectionSystem Organ Class: 100000004862MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2012-003984-23-ESFundació Clínic per a la Recerca Biomèdica
进行中（未招募）
不适用
A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children age 2 years through 6 yearsHealthy ChildrenEUCTR2014-003401-15-Outside-EU/EEAAstraZeneca K.K.100
进行中（未招募）
3 期
on-interference immune response study of inactivated Japanese encephalitis vaccine (JENVAC�®) when co-administered with Measles, Mumps and Rubella (MMR) vaccineCTRI/2021/06/034403Bharat Biotech International Limited
进行中（未招募）
不适用
An Open Label Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult Population - Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine.To verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season, manufactured according to the standard manufacturing process using a fixed Trition-X concentration during the splitting process (Formula A) (Cohort 1) and a modified manufacturing process control using a fixed protein to Triton X-100 ratio during the splitting process of the H3N2 and the B strain (Formulation B) (Cohort 2)MedDRA version: 12.1Level: LLTClassification code 10022000Term: InfluenzaEUCTR2009-017781-23-BEBaxter Innovations GmbH220