Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Conversion to TacroBell SR Cap.(Once-Daily Tacrolimus) in Patients Undergoing Maintenance Therapy With Twice-Daily Tacrolimus After Liver Transplantation.
试验速览
- 阶段
- 4 期
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Incidence of composite efficacy failure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.
详细描述
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus.
Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one year after liver transplantation
- •Over 20 years old(male or female)
- •Patient taking tacrolimus twice daily as a maintenance therapy
- •Patients with Tacrolimus blood levels of 3-10 at screening
- •Agreement with written informed consent
排除标准
- •Previously transplanted another organs other than the liver or at the same time
- •Diagnosed and clinically treated with acute rejection within the last 6 months
- •Patients who have changed the method of administering concomitant immunosuppressants or steroids within the last month
- •Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled]
- •Patients who have positive HIV test result
- •Severe systemic infection requiring treatment
- •At screening
- •White blood cell count < 1,500/mm^3, or platelet < 50,000/mm^3, or Serum-C r> 2.0mg/dl
- •Liver function test(T-bilirubin, aspartate aminotransferase, alanine aminotransferase)is over 3 times than upper normal limit
- •Patients Taking HCV(hepatitis C virus) Therapeutic Drugs
- •Pregnant women or nursing mothers
- •Fertile women who not practice contraception with appropriate methods
- •Participated in other trial within 4 weeks
- •In investigator's judgment
研究组 & 干预措施
Conversion to Once-daily Tacrolimus
Conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation
干预措施: Conversion to Once-daily Tacrolimus (Drug)
结局指标
主要结局
Incidence of composite efficacy failure
时间窗: until 24 weeks
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
次要结局
- Pathological results of acute rejection(until 24 weeks)
- Incidence of biopsy-confirmed acute rejection(until 24 weeks)
- Survival rate of transplanted organ(at 24 weeks)
- Survival rate of Patients(at 24 weeks)
- Serum-Cr, eGFR(estimated glomerular filtration rate)(at 24 weeks)
- Evaluate safety of TacroBell SR. cap. from number of participants with adverse events(until 24 weeks)