Health Condition 1: null- Liver Transplant
Conditions
Interventions
Intervention1: Enteric-coated mycophenolate sodium: Mycophenolate sodium is an immunosuppressant drug.It is the sodium salt of the active moiety, mycophenolic acid.Gastro-resistant tablets.
Dose: 360
Sponsors
Medanta The Medicity
Dr Arvinder Singh Soin
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Incidence and severity of GI adverse events of MPA in patients using MMF and EC-MPS 2 Determine the number of patients in whom dose reductions or drug discontinuation was required because of GI side effects Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Record other side effects of MPA such as anemia, leukopenia, thrombocytopenia 2 Record any incidences of biopsy confirmed acute rejection, time to rejection and treatment given for the same Timepoint: During 12 months | — |
Countries
India
Contacts
Public ContactMegha Bhardwaj
Medanta â?? The Medicity
Outcome results
None listed