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

Liver Transplantation Clinical Trial

Official title:

Single Center, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241043
• Other study ID #: PAKT CTC 151043
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Treatment 2 weeks Envarsus followed by 2 weeks Advagraf

• Treatment 2 weeks Advagraf followed by 2 weeks Envarsus

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAV (average cumulative dose) = cumulative dose per study period/ period days		20 month
Primary	C0/doses (trough level at steady state / daily dose at steady state)		20 month
Primary	AUC0-24/doses		20 month