NCT01882322已完成4 期
A Phase IV, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Advagraf® (Modified Release Tacrolimus, Once Daily) After Using Prograf® (Tacrolimus Twice Daily) in de Novo Liver Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Incidence of biopsy-confirmed acute rejection
研究概览
简要总结
The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.
详细描述
De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while Prograf therapy will be continued in other group.
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
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject scheduled for liver transplantation from a living donor or brain dead
- •In case of a woman of childbearing potential, a subject with a negative pregnancy test prior to enrollment and who consents to and would practice double contraception throughout the study (Pessary therapy, or rhythm method, or sexual abstinence, surgical sterilization, menopause or otherwise sterile; however, oral contraceptives are excluded.)
- •A subject with terminal hepatic failure for which liver transplant is necessary
- •A subject who understands and is completely aware of the study objective and risks and who submitted a written informed consent form on study participation
排除标准
- •A subject who received multiple organ transplants or any previous organ transplant (including re-transplantation of the liver)
- •A subject who had received auxiliary transplant or used the bioartificial liver (cellular system)
- •A subject allergic or resistant to macrolide antibiotics or Tacrolimus
- •A subject who was taking Cyclosporine and Bosentan (Tracleer) that may interact with Tacrolimus, or potassium-sparing diuretics known to possibly cause hyperkalemia (Spironolactone, Triamterene) at screening
- •A subject who requires immunosuppressive treatment or systemic chemotherapy from before transplant. However, a subject who received immunosuppressive treatment for less than 1 month prior to transplant to treat underlying hepatic disorder may be enrolled in the study if treatment is discontinued at the time of transplant.
- •A subject with malignancy or malignant tumor history within the past 5 years; however, a subject may be enrolled in this study in case of successfully cured for basal cell carcinoma or squamous cell carcinoma of the skin.
- •A subject who suffers severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect Tacrolimus absorption (may be determined at the discretion of the investigator)
- •A subject with any type of substance abuse, psychological disorder, or communication disorder at the discretion of the investigator
- •A subject who is participating in another study or participated within 28 days of the study, or who had received IP or non-registered medication
- •A subject who is pregnant or breastfeeding
- •A subject (transplant recipient) and/or donor who are positive to HIV
- •A subject who cannot comply with the protocol-planned routine visit schedule
- •A subject who is not appropriate for study participation at the discretion of the investigator
研究组 & 干预措施
Advagraf conversion group
Experimental
Oral
干预措施: Prograf (Drug)
Advagraf conversion group
Experimental
Oral
干预措施: Advagraf (Drug)
Prograf maintenance group
Active Comparator
Oral
干预措施: Prograf (Drug)
结局指标
主要结局
Incidence of biopsy-confirmed acute rejection
时间窗: from Week 4 to Week 24 post-transplant
Acute rejection incidence (%) = Number of subjects with at least one biopsy -confirmed acute rejection / Total number of subjects included in the relevant analysis set \* 100
次要结局
- Severity of biopsy-confirmed acute rejection(from Week 4 to Week 12 and Week 24 after liver transplant)
- Incidence of biopsy-confirmed acute rejection(from Week 4 to Week 12 or Week 24)
- Subject survival rate and graft survival rate(from Week 4 to Week 12 and Week 24 after liver transplant)
- Safety assessed by the incidence of adverse events, vital signs, physical exam. and labo-tests(for 24 weeks after liver transplant)
研究者
相似试验
已完成
4 期
Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B InfectionHepatitis B, ChronicNCT02097004Seoul National University Hospital111
Unknown
4 期
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received TreatmentHIV InfectionsNCT00005017Glaxo Wellcome300
招募中
3 期
A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With AsthmaAsthmaNCT05562466Novartis Pharmaceuticals200
Unknown
4 期
Injection Assistance Device Versus Manual Injections for Delivery of Dermal FillersCorrection of Nasolabial FoldsNCT01492140TKL Research, Inc.50
终止
3 期
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis ExternaOtitis ExternaNCT01910155Par Pharmaceutical, Inc.455