Efficacy and safety evaluation of Suprotac® in comparison with Prograf® in prevention of liver transplant rejectio

Phase 4

Recruiting

• Conditions: iver transplant.; Liver transplant status; Z94.4

• Registration Number: IRCT20150303021315N25
• Lead Sponsor: anoalvand Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Patient aged between 18 to 70 years
Patient who has passed two months from transplantation surgery
Patient who has received a stable dose of tacrolimus (prograf®) in the last 14 days before enrolment
Ability to comprehend and willing to sign the informed consent form for this study

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 who underwent liver transplant rejection in the first two months after liver transplantation
Patients with Glomerular Filtration Rate greater than 30 at the time of enrolment to the study (two months after liver transplantation)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).