Liver transplant. Liver transplant status
Conditions
Interventions
Intervention 1: Intervention group: Suprotac® (Nanoalvand) is administered at a dose of 0.1–0.15 mg/kg orally on the first day post-transplant. Then, dose will be adjusted if needed to reach the desir
Sponsors
Nanoalvand Company
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patient aged between 18 to 70 years Ability to comprehend and willing to sign the informed consent form for this study
Exclusion criteria
Exclusion criteria: Use of other investigational drugs at the time or within 30 days of enrolment, or within five half-lives of those drugs, whichever is longer (except for dialysis-related drugs which are not expected to interact with the study regimens) Patients with contraindication for tacrolimus or any other ingredients of the formulation Patients with Glomerular Filtration Rate greater than 30 at the time of enrolment to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplantation rejection. Timepoint: All along the study duration until one year after transplantation surgery. Method of measurement: Liver transplant rejection approved by biopsy or clinical symptoms and laboratory tests (enhancement in alanine aminotransferase or aspartate aminotransferase liver enzymes). | — |
Secondary
| Measure | Time frame |
|---|---|
| Death. Timepoint: All along the study duration until one year after transplantation surgery. Method of measurement: Incidence of death written in the adverse event’s section of the case report form.;Graft loss. Timepoint: All along the study duration until one year after transplantation surgery. Method of measurement: Transplant rejection not responsive to the treatment according to the biopsy or clinical symptoms and laboratory tests (enhancement in alanine aminotransferase or aspartate aminotransferase liver enzymes).;Mean trough concentration per dose of tacrolimus. Timepoint: Baseline, months 2, 4, 6 and 10. Method of measurement: Dividing trough concentration to the consumed daily dose.;Adverse events. Timepoint: Baseline, months 2, 4, 6 and 10. Method of measurement: All adverse events are assessed through patient reporting, physician diagnosis, or laboratory abnormalities, and are then classified by severity (based on Common Terminology Criteria for Adverse Events (CTCAE)), seriousness, relationship to the study drug, action taken, and outcome. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
Orchid Pharmed
Outcome results
None listed