EUCTR2015-001076-22-Outside-EU/EEA进行中（未招募）不适用
A PHASE II, OPEN-LABEL, MULTI-CENTER STUDY TO ASSESS THE PHARMACOKINETICS, LONG-TERM SAFETY AND TOLERABILITY OF TACROLIMUS IN STABLE PEDIATRIC LIVER TRANSPLANT PATIENTS CONVERTED FROM A PROGRAF® BASED IMMUNOSUPPRESSION REGIMEN TO A MODIFIED RELEASE (MR) TACROLIMUS BASED IMMUNOSUPPRESSION REGIME
Fujisawa Healthcare, Inc.0 个研究点目标入组 16 人开始时间: 2015年4月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Legal guardian has been fully informed and has signed an IRB approved informed consent form/authorization. Patient, ages 7-12, has been fully informed and has signed an IRB approved assent form/authorization.
- •2. Patient is the recipient of a liver transplant at least six months prior to enrollment.
- •3. Patient is < 12 years of age.
- •4. Patient is currently receiving Prograf based (whole mg total daily dose and equivalent AM/PM dosing) immunosuppressive therapy for liver transplantation. Patient is able to swallow whole intact capsules.
- •5. The total daily dose of each immunosuppression medication (including corticosteroids) has remained unchanged for the last 2 weeks prior to entry into the study. Corticosteroid dose not to exceed 20 mg/day.
- •6. Patient has stable whole blood trough level concentrations of Prograf (defined as tacrolimus trough concentrations of 5-20 ng/mL measured on at least 2 separate occasions taken at least 6 days apart within 30 days prior to enrollment), and is clinically stable in the opinion of the Investigator.
- •7. Female patients who have started their menses must have a negative urine or serum pregnancy test within 14 days prior to enrollment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 16
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has previously received an organ transplant other than a liver.
- •2. Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy or more than 2 rejection episodes within the last 12 months.
- •3. Patient is currently receiving sirolimus immunosuppression therapy.
- •4. Patient has any unstable medical condition that could interfere with the study objectives.
- •5. Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment.
- •6. Patient has a history or presence of malignancy (except for treated basal or squamous cell carcinoma of the skin), serious active or recurrent infection or any medical condition or disorder that, in the opinion of the investigator, precludes the patient from participating in this study.
- •7. Patient has a known hypersensitivity to tacrolimus.
- •8. Patient is pregnant or lactating, for female patients who have started their menses.
- •9. Patient is unlikely to comply with the scheduled visits.
- •10. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator.
- •11. Patient is currently receiving any medications described in Appendix C.
- •12. Patient’s liver function is abnormal, as defined by AST/ALT > 2 x ULN at screening.
- •13. Patient’s renal function is abnormal, as defined by calculated creatinine clearance < 50 mL/min/m2 using the Schwartz formula.
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