Status:
COMPLETED
Study to Evaluate Pharmacokinetic and Bioavailability of Envarsus® vs. Advagraf® in Liver Transplant Recipients
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Single centre, open-label, randomized, controlled, cross over study to evaluate the pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in de novo liver transplant recipients
Detailed Description
Using an open-label, randomized, controlled, 2-period cross-over design, two treatments (Envarsus® and Advagraf®) will be compared (with regard to PK profile and bioavailability) after administration ...
Eligibility Criteria
Inclusion
- Ability to understand the patient information and to personally sign and date the informed consent to participate in the clinical trial, before completing any clinical trial related procedures.
- Male or female recipients ≥ 18 years of a liver graft from a deceased or living donor
- The patient must receive a twice daily Tacrolimus based immunosuppression treatment.
- Females of child-bearing potential who agree to comply with any applicable contraceptive requirements of the protocol or females who are permanently sterilized (at least 6 weeks post sterilization).
- Non-pregnant, non-lactating female.
- Recipients of a first or re-liver transplant in the last 30 days
- The patient is co-operative and available for the entire clinical trial.
Exclusion
- Patients with a known hypersensitivity to any of the drugs used in the study.
- Patients who are not able to take oral medication at the time point of randomization.
- Recipients of combined organ transplants.
- Patients who are recipients of AB0 incompatible transplant grafts.
- Currently participation in a clinical trial and any IMP intake within the last four weeks.
- Patients who use drugs known to strongly interact with the cytochrome P-450 3A4 pathway and therefore influence the tacrolimus blood level are not allowed during Envarsus®/Advagraf® treatment period.
- Patient with renal impairment with need of dialysis treatment at the time point of randomization.
- Patient with a quick value \< 30 %
- Patient with a thrombocytopenia \<20 Mrd./L
- Patients with a leukopenia \< 1.0 Mrd. / L
- Patients with inability of oral food intake.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03241043
Start Date
May 1 2016
End Date
April 1 2019
Last Update
May 4 2021
Active Locations (1)
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1
University Hospital Hamburg-Eppendorf
Hamburg, Germany