EUCTR2005-001102-31-DE进行中（未招募）不适用
A phase II, open-label, multi-centre study to assess the effect of single and multiple oral doses (1 mg, 2 mg, and 3 mg) of everolimus on the pharmacokinetics of tacrolimus in stable renal transplant patients - TEAK Study (Tacrolimus and Everolimus in Allograft Kidney transplantation)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. Male or female patients aged 18 - 65 years.
- •2. Female patient of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control (such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner) during the study and 8 weeks after treatment with everolimus has been stopped.
- •3. Stable Tacrolimus/MMF(CellCept®) or Tacrolimus/Mycophenolate Sodium(Myfortic®) dose regimen with or without steroids for at least 2 weeks prior to study.
- •4. Stable renal transplant patient for 6 months or more who have been treated with tacrolimus as base immunosuppressant.
- •5. Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed by an independent person.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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 kidney.
- •2. Patient who requires azathioprine, rapamycin or everolimus immunosuppressive therapy.
- •3. Patient with a malignancy within the last 6 months (except when the malignancy will not require further treatment and in the opinion of the investigator will not influence the patient´s health during the study period). Patients with non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully can be included even when the occurence was within the last 6 months.
- •4. Patient has a systemic infection requiring treatment.
- •5. Patient with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
- •6. Patient with concomitant medication known to affect tacrolimus pharmacokinetics which might not remain stable for the duration of the study.
- •7. Patients with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
- •8. Patient is simultaneously participating in another investigational drug study or has participated in such study within 28 days before entry in this study.
- •9. Patient who had previously participated in this study.
- •10. Patient is receiving non-registered medication or has received such non-registered medication within 28 days before entry in this study.
- •11. Patient is pregnant or breast-feeding mother.
- •12. Patient or donor is known to be positive for HBV, HCV or HIV.
- •13. Patient is unlikely to comply with the visits scheduled in the protocol.
- •14. Patients with a known hypersensitivity to everolimus, sirolimus, or to any of the excipients.
- •15. Patients with severe hepatic impairment defined as having during the past 30 days continously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 2 times the upper value of the normal range of the investigational site.
- •16. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
研究者
相似试验
进行中（未招募）
不适用
A phase II, open-label, multi-centre study to assess the effect of single and multiple oral doses (1 mg, 2 mg, and 3 mg) of everolimus on the pharmacokinetics of tacrolimus in stable renal transplant patients - TEAK Study (Tacrolimus and Everolimus in Allograft Kidney transplantation)EUCTR2005-001102-31-HUAstellas Pharma GmbH30
进行中（未招募）
1 期
Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.EUCTR2013-002202-31-DEPolyphor Ltd.20
进行中（未招募）
不适用
Study conducted in several hospitals to check the distribution of study medication(POL7080) in the body, and to verify its safety and its capacity to cure when given in addition to standard treatment for patients with pneumonia caused by bacterium Pseudomonas aeruginosa, following artificial ventilation.Ventilator- associated pneumonia due to suspected or documented Pseudomonas aeruginosa infection.EUCTR2013-001596-21-ESPolyphor Ltd20
进行中（未招募）
1 期
Study conducted in several hospitals to check the distribution of study medication(POL7080) in the body, and to verify its safety and its capacity to cure when given in addition to standard treatment for patients with pneumonia caused by bacterium Pseudomonas aeruginosa, following artificial ventilation.EUCTR2013-001596-21-GRPolyphor Ltd20
进行中（未招募）
1 期
Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.EUCTR2013-002202-31-GBPolyphor Ltd.12