Liver TransplantationPhase 3NCT03241043
Study to Evaluate Pharmacokinetic and Bioavailability of Envarsus® vs. Advagraf® in Liver Transplant Recipients
A Phase 3 study testing Treatment 2 weeks Envarsus followed by 2 weeks Advagraf and Treatment 2 weeks Advagraf followed by 2 weeks Envarsus in people with Liver Transplantation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Treatment 2 weeks Envarsus followed by 2 weeks Advagraf and Treatment 2 weeks Advagraf followed by 2 weeks Envarsus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Apr 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Treatment 2 weeks Envarsus followed by 2 weeks Advagraf, Treatment 2 weeks Advagraf followed by 2 weeks Envarsus
- Keywords
- Pharmacokinetic study, Comparing Envarsus versus Advagraf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment 2 weeks Envarsus followed by 2 weeks AdvagrafDrug
Treatment 2 weeks Advagraf followed by 2 weeks EnvarsusDrug
| Study group | Role | What they receive |
|---|---|---|
| Envarsus - Advagraf | Experimental | Not described Receives: Drug: Treatment 2 weeks Envarsus followed by 2 weeks Advagraf |
| Advagraf - Envarsus | Active comparator | Not described Receives: Drug: Treatment 2 weeks Advagraf followed by 2 weeks Envarsus |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAV (average cumulative dose) = cumulative dose per study period/ period days
Measured: 20 month
C0/doses (trough level at steady state / daily dose at steady state)
Measured: 20 month
AUC0-24/doses
Measured: 20 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startMay 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herden, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241043
- Sponsor's protocol ID
- PAKT CTC 151043
- Status last verified
- May 2021
- First submitted
- 12 Sep 2016
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03241043
- Acronym / sponsor ID
- PAKT CTC 151043
- Conditions
- Liver Transplantation
- Keywords
- Pharmacokinetic study, Comparing Envarsus versus Advagraf
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Envarsus - Advagraf | Experimental | Drug: Treatment 2 weeks Envarsus followed by 2 weeks Advagraf |
| Advagraf - Envarsus | Active comparator | Drug: Treatment 2 weeks Advagraf followed by 2 weeks Envarsus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment 2 weeks Envarsus followed by 2 weeks Advagraf | Drug | Envarsus - Advagraf |
| Treatment 2 weeks Advagraf followed by 2 weeks Envarsus | Drug | Advagraf - Envarsus |
Primary outcome
DAV (average cumulative dose) = cumulative dose per study period/ period days
Time frame: 20 month
C0/doses (trough level at steady state / daily dose at steady state)
Time frame: 20 month
AUC0-24/doses
Time frame: 20 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herden principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment 2 weeks Envarsus followed by 2 weeks Advagraf and Treatment 2 weeks Advagraf followed by 2 weeks Envarsus in people with Liver Transplantation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAV (average cumulative dose) = cumulative dose per study period/ period days (time frame: 20 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.