An Observational, Prospective, Open label study comparing enteric-coated mycophenolate sodium (EC-MPS) with Mycophenolate mofetil (MMF) with calcineurin inhibitor (CNI) de-novo in patients after primary liver transplant. - na

Medanta The Medicity0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1 Patient of either gender who are aged 18 to 70 years
•2 Patient is a primary living donor liver transplant recipient
•3 Female patients of child bearing potential must have a negative urine or serum pregnancy test before transplant
•4 Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
•5 Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen

•1 Patient has previously received or is receiving an organ transplant other than a liver,Multi-organ transplant patients.
•2 Patient has received a liver transplant from a deceased donor, an ABO incompatible donor liver
•3 Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
•4 Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
•5 Patients with thrombocytopenia (30,000/mm3), and/or leukocytopenia (2,000/mm3) with an absolute neutrophil count of 1,000/mm3 and/or hemoglobin 7.0 g/dL prior to enrollment.
•6 Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
•7 Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
•8 Patient has a known hypersensitivity to tacrolimus or cyclosporine, enteric-coated mycophenolate sodium or corticosteroids
•9 Patient is pregnant or lactating
•10 Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves

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