Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Islet Graft Function
研究概览
简要总结
Primary objective: To describe and compare the safety and efficacy of treatment with AAT in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT).
详细描述
The goal of this study is to assess whether infusion of Prolastin-C during peri-transplant period can enhance islet autograft survival and function in chronic pancreatitis patients who have total pancreatectomy and islet autotransplantation. This is a prospective, controlled, double-blind study. The primary endpoint will be area under the curve for the serum C-peptide level during the first 4 hours of an mixed meal tolerance test (MMTT), normalized by the number of islet equivalents (IEQ)/kg at day 365±14 after the transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for total pancreatectomy and islet auto-transplantation
- •Age > 18 years
- •Diabetes free before surgery
排除标准
- •Patients who are under immunosuppression
- •Patients who have had Puestow or Frey pancreatic surgery
- •Patients who have Immunoglobulin A (IgA) deficiency, known antibodies against IgA, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to Alpha1-proteinase inhibitor products (allergic to AAT)
研究组 & 干预措施
Prolastin-C
Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks.
干预措施: Prolastin-C (Drug)
Placebo
Subjects will be given Saline weekly for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Islet Graft Function
时间窗: 365 days
Islet graft function will be measured by 4 hour mixed meal tolerance test (MMTT) at 365 days post transplantation. Specific measurement is the C-peptide area under the curve (AUC)
次要结局
未报告次要终点
研究者
Hongjun Wang
Professor of Surgery
Medical University of South Carolina