An Open-label, Prospective, Single-arm, Multi-center, Phase IV Study to Assess the Safety of Addaven in Adult Subjects Requiring Parenteral Nutrition After Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 4
- 主要终点
- Incidence of Treatment Treatment-Emergent Adverse Events (TEAEs adverse events (AEs) occurring after the onset of infusion of the first study drug dose till next calendar day after the last study drug dose)
研究概览
简要总结
This is a phase IV, open-label, prospective, single-arm, multicenter study to evaluate the safety of Addaven in adult patients requiring parenteral nutrition after surgery. Addaven is a trace element concentrate containing chromium, copper, iron, manganese, iodine, fluoride, molybdenum, selenium, and zinc. The study aims to assess the incidence of treatment-emergent adverse events and adverse drug reactions following administration of Addaven for four consecutive days as part of postoperative parenteral nutrition. Approximately 188 subjects undergoing elective major abdominal surgery will be enrolled across multiple sites in India. Safety assessments will include adverse event monitoring, changes in vital signs, and clinical laboratory evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex, above or equal 18 to below or equal 65 years of age
- •A voluntarily given informed consent form (ICF) from the subject, or legally acceptable representative (in case the subject is not able)
- •Subjects from Indian population
- •Subjects with an indication for PN during the postoperative period, with an anticipated duration of 4 consecutive days—subjects scheduled to undergo elective major abdominal surgery, including surgery for cancer and non-cancer reasons (e.g., oesophageal resection, gastrectomy, pancreatoduodenectomy, partial pancreatectomy, small bowel resection, colon resection surgery, etc.)
- •Body mass index above or equal to 16 or below or equal to 30 kg/m².
排除标准
- •Subjects with known allergy or hypersensitivity to the active substances or any excipients of the study drug
- •Congestive cardiac failure, or other forms of cardiopulmonary instability, e.g., cardiac arrhythmias, conditions associated with low cardiac output, hypoxemia with or without respiratory failure, shock, or blood pressure outside its normal range
- •Acute or chronic kidney disease in need of renal replacement therapy (acute kidney injury 2-3 and/or KDIGO Chronic Kidney Disease stages 4-5)
- •Conditions with total biliary obstruction, like gallstones, cysts, cirrhosis, tumors, liver/biliary tract trauma, among others
- •Hepatic failure, defined as impaired liver synthetic and metabolic function
- •Wilson’s disease
- •Known or suspected hemochromatosis, hemosiderosis
- •Known or suspected pregnancy at the time of enrollment
- •Breastfeeding mothers during the study period
- •Participation in other clinical trial(s) during this study, or within the previous 4 weeks of its start
- •Subjects with known or suspected alcohol or drug abuse
- •Subjects taking any oral supplements or any beverages containing high amounts of TEs 1 week before and during the study
- •Any other clinical condition, which, in the opinion of the Investigator, could interfere with the study protocol, or affect subjects’ safety in the study.
结局指标
主要结局
Incidence of Treatment Treatment-Emergent Adverse Events (TEAEs adverse events (AEs) occurring after the onset of infusion of the first study drug dose till next calendar day after the last study drug dose)
时间窗: From Day 1 of Addaven infusion until one calendar day after the last infusion (i.e., Day 5 or Day 6)
次要结局
- Incidence of Adverse Drug Reactions (ADRs)(From Day 1 to Day 5/6 (one day after last dose))
- Vital signs, physical examination, laboratory evaluation(Screening, enrollment and from Day 1 to Day 4; final assessment on Day 5/6)
研究者
Dr Antaryami Maharana
Abiogenesis Clinpharm Private Limited