EUCTR2009-012231-15-DE进行中（未招募）不适用
Pharmacokinetics of Mycophenolate Mofetil in de novo lung allograft recipients - CELMACS
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Patient received a primary single or bilat-eral lung allograft.
- •2.Primary reason for lung transplantation was cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or alpha-1 antitrypsin deficiency.
- •3.According to center practice patient re-ceives corticosteroids and cyclosporine as part of the immunosuppressive regime.
- •4.Patient is 18 years of age or older.
- •5.Patient is capable of understanding the purposes and risks of the study and is able to reliably report any adverse event.
- •6.Patient is willing to give written informed consent, written consent for data protec-tion and willingness to participate and to comply with the study.
- •7.Females of childbearing potential will have a negative pregnancy test at screening.
- •8.Patient agrees to utilize contraceptive methods throughout the study period, dur-ing treatment with mycophenolate mofetil and for 6 weeks following discontinuation of therapy
- •9. In general, women of childbearing potential should be using highly effective contraception to participate in clincial studies. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1 % per year) when used consistently and corrrectly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Retransplanted lung allograft recipients or multiple organ transplant recipients.
- •2.Patient has severe diarrhea or other gas-trointestinal disorder including biliary dis-ease interfering with his / her ability to ab-sorb oral medication. Cystic fibrosis is not an exclusion criterion.
- •3.Patient received an investigational new drug within the last 30 days.
- •4.Patient participates simultaneously in an-other clinical trial.
- •5.Patient participated in this study before.
- •6.Women lactating, pregnant or of childbear-ing potential not using a reliable contra-ceptive method.
- •7.Patient is underage or incapable to under-stand the aim, importance and conse-quences of the study and to give legal in-formed consent according to §40 Abs. 4 and §41 Abs. 2 and Abs. 3 AMG.
- •8.Patient has a history of psychiatric illness or condition such as to interfere with the patient´s ability to understand the require-ments of the study.
- •9.Patients who possibly are dependent on the sponsor or investigator.
- •10.Patient has exhibited in the past an allergic or other significant adverse reaction to my-cophenolate mofetil.
- •11.Patient has liver function test results greater than 3 times the upper limit of nor-mal (ULN).
- •12.Patient is positive for HIV or Hepatitis C.
- •13.Patient is positive for HBsAg and/or HBV-DNA. Inclusion of patients positive for anti-HBs and/or anti-HBc but negative for HBsAg and/or HBV-DNA is permitted.
- •14.Patients with malignancies or history of malignancy.
- •15.Patient has a current severe illness or any other condition(s) (e.g. psychiatric disor-der) which would make the subject in the opinion of the investigator unsuitable for the study.
- •16.Patient received prohibited medication as defined in section 4.5
研究者
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