Safety and efficacy of human lactoferrin hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients

AM-Pharma B.V. (Netherlands)0 个研究点目标入组 8 人开始时间: 2006年6月9日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Admitted for an autologous hematopoietic stem cell transplantation (HSCT) after myeloablative therapy with high-dose melfalan
•2. Managed with a 4-lumen central venous catheter
•3. 18 to 45 years of age
•4. Body mass index (BMI) <30
•5. Able and willing to participate
•6. Has provided written informed consent
•7. There is no medical reason for exclusion
•8. Has adequate renal function (creatinine <110 µmol/l [man]; <90 µmol/l [woman])
•9. Has adequate liver function aspartate aminotransferase (ASAT) <40 U; alanine aminotransferase (ALAT) <45 U; bilirubin <10 µmol/l)
•10. Has no known allergy to lactoferrin
•11. Has no history of hepatitis and is not human immunodeficiency virus (HIV)-seropositive
•12. If a woman, functionally post-menopausal

•1. A history of, or presence of, significant respiratory, cardiovascular, neurological, haematological, endocrine, gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs (as judged clinically relevant by the investigator)
•2. Participation in a study with a new chemical entity or new molecular entity 3 months before or participation in a study with a registered drug less than 5 times of the half life of the registered drug before entering the study
•3. A clinically relevant history of intolerance or hypersensitivity to the study drug, or its additives and excipients in the intravenous formulation
•4. Evidence of having serum hepatitis or carrying the hepatitis B surface antigen or hepatitis C antibodies or being HIV positive
•5. Subjects, who in the opinion of the investigator should not, for reasons of safety, participate in the study

发起方

AM-Pharma B.V. (Netherlands)