A Prospective, Multi-center, Open-labeled, Randomized Clinical Trial of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant Recipients to Compare QD Early Conversion and BID Tacrolimus Formulation.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Adherence of administration of Advagraf in newly Taiwanese (Chinese) liver transplant patients.
研究概览
简要总结
A study of patient adherence and convenience to immunosuppressive agents in newly liver transplant recipients - a prospective, multi-center, open-labeled, randomized clinical trial for comparison between once-daily early conversion and twice-daily tacrolimus formulation.
详细描述
This is prospective, multi-center, open-labeled, randomized study to investigate adherence of administration of once-daily tacrolimus formulation (Advagraf®) in newly Taiwanese (Chinese) liver transplant patients. The procedure of liver transplantation will follow the site-specific procedure. Each subject will be randomized on postoperative day 15 (POD15; defined Day 14 +/- 1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open labeled
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been fully informed and has signed an IRB approved informed consent form within 7 days (Day 7-13) prior to POD 15 and is willing and able to follow study procedure
- •Patient is a primary liver transplant recipient
- •Patient is 20 to 70 years of age
- •Patient should be clearly conscious, fully understand and able to answer questionnaire
排除标准
- •Patient has previously received or is receiving an organ transplant other than a liver.
- •Patient currently requires dialysis
- •Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- •Patient has received a liver transplant from a non-heart beating donor
- •Patient who is HCV negative has received an HCV positive (HCV RNA by PCR or HCV antibody) donor liver
- •Patient who is HbsAg negative has received an HbsAg positive (HBV DNA by PCR or HBV antibody) donor liver
- •Patient has received a liver transplant from a decrease donor > 70 years of age
- •Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully.
- •Patient is hemodynamically unstable on POD 15
研究组 & 干预措施
Experimental Arm
Switch from Prograf to Advagraf on POD 15
干预措施: Advagraf (Drug)
Control Arm
Continue Prograf treatment
干预措施: Prograf (Drug)
结局指标
主要结局
Adherence of administration of Advagraf in newly Taiwanese (Chinese) liver transplant patients.
时间窗: Visit 1 (Day 14) to Visit 6 (Day 364) - 50 weeks observation
• The adherence of enrolled 150 subjects will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS)
次要结局
未报告次要终点
研究者
Wei-Chen Lee
Professor
Chang Gung Memorial Hospital