NCT05788588进行中（未招募）3 期
A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Confirmatory Study to Evaluate the Efficacy and Safety of HR19006 Injection for Postoperative Parenteral Nutrition
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Serum prealbumin level on the 6th day after operation.
研究概览
简要总结
This is a phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory study, and the purpose of the study is to evaluate the efficacy and safety of HR190006 for postoperative parenteral nutrition via central venous catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent;
- •Elective operation of Gastrointestinal;
- •Male or female，aged 18-80 years inclusive;
- •Body Weight at least 40kg, Body mass index (BMI) 18.5-30 kg/m2 inclusive;
- •Nutrition Risk Screening (NRS2002) score at least 3 points.
排除标准
- •Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients;
- •Congenital amino acid metabolism abnormality;
- •Hypothyroidism or hyperthyroidism;
- •Significant abnormal values of clinical laboratory examination;
- •Uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure);
- •General contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency;
- •Subjects with a history of mental system diseases and cognitive dysfunction;
- •Serious complications during or after operation;
- •Previous (< 2 weeks) received treatment with intravenous nutrition;
- •Previous (< 4 weeks) or ongoing treatment with growth hormone or corticosteroids;
- •Pregnant or nursing women;
- •No birth control during the specified period of time;
- •Participated in clinical trials of other drugs (received experimental drugs);
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
HR19006
Experimental
干预措施: HR19006 (Drug)
All-in-one parenteral nutrition
Active Comparator
干预措施: All-in-one parenteral nutrition (Drug)
结局指标
主要结局
Serum prealbumin level on the 6th day after operation.
时间窗: on day 6 postoperation
次要结局
- The changes of linoleic acid level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The changes of IL-6 level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The changes of TNF-α level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The changes of linolenic acid level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The changes of EPA level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The changes of DHA level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The change of serum prealbumin level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The incidence of new postoperation infection.(on days 1 and 6 post operation)
- The changes of arachidonic acid level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
- The changes of CRP level from baseline on the 6th day after operation.(on days 1 and 6 post operation)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive EsophagitisErosive Esophagitis (EE)NCT03615677Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.261
已完成
3 期
Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute UrticariaAcute UrticariaNCT02935699JDP Therapeutics, Inc.262
已完成
3 期
Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent AsthmaAsthmaNCT01687283GlaxoSmithKline316
已完成
3 期
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01500226Tesaro, Inc.1,369
已完成
3 期
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01499849Tesaro, Inc.532