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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03241043
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Treatment 2 weeks Envarsus followed by 2 weeks Advagraf Drug: Treatment 2 weeks Advagraf followed by 2 weeks Envarsus Phase 3

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®).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Envarsus - Advagraf Drug: Treatment 2 weeks Envarsus followed by 2 weeks Advagraf
Active Comparator: Advagraf - Envarsus Drug: Treatment 2 weeks Advagraf followed by 2 weeks Envarsus

Primary Outcome Measures :
  1. DAV (average cumulative dose) = cumulative dose per study period/ period days [ Time Frame: 20 month ]
  2. C0/doses (trough level at steady state / daily dose at steady state) [ Time Frame: 20 month ]
  3. AUC0-24/doses [ Time Frame: 20 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03241043

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Contact: Uta Herden, PD Dr.
Contact: Bjoern Nashan, PD Dr.

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University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Uta Herden, PD Dr.   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Herden Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT03241043     History of Changes
Other Study ID Numbers: PAKT CTC 151043
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Pharmacokinetic study
Comparing Envarsus versus Advagraf

Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action