Study to Evaluate Pharmacokinetic and Bioavailability of Envarsus® vs. Advagraf® in Liver Transplant Recipients

NCT ID: NCT03241043

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-04-30

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 of IMP to 20 de novo transplanted recipients. The patients will be randomly assigned to one of the two treatments as treatment period 1 and afterwards switched to treatment period 2 (Group 1: Envarsus® - Advagraf®; Group 2: Advagraf® - Envarsus®).

Conditions

Liver Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Envarsus - Advagraf

Group Type: EXPERIMENTAL

Treatment 2 weeks Envarsus followed by 2 weeks Advagraf

Intervention Type: DRUG

Advagraf - Envarsus

Group Type: ACTIVE_COMPARATOR

Treatment 2 weeks Advagraf followed by 2 weeks Envarsus

Intervention Type: DRUG

Interventions

Treatment 2 weeks Envarsus followed by 2 weeks Advagraf

Intervention Type: DRUG

Treatment 2 weeks Advagraf followed by 2 weeks Envarsus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Male or female recipients ≥ 18 years of a liver graft from a deceased or living donor

3. The patient must receive a twice daily Tacrolimus based immunosuppression treatment.

4. 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).

5. Non-pregnant, non-lactating female.

6. Recipients of a first or re-liver transplant in the last 30 days

7. The patient is co-operative and available for the entire clinical trial.

Exclusion Criteria

1. Patients with a known hypersensitivity to any of the drugs used in the study.

2. Patients who are not able to take oral medication at the time point of randomization.

3. Recipients of combined organ transplants.

4. Patients who are recipients of AB0 incompatible transplant grafts.

5. Currently participation in a clinical trial and any IMP intake within the last four weeks.

6. 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.

7. Patient with renal impairment with need of dialysis treatment at the time point of randomization.

8. Patient with a quick value < 30 %

9. Patient with a thrombocytopenia <20 Mrd./L

10. Patients with a leukopenia < 1.0 Mrd. / L

11. Patients with inability of oral food intake.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herden

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Hospital Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

PAKT CTC 151043

Identifier Type: -

Identifier Source: org_study_id