de Novo Liver TransplantationPhase 1NCT00545259
Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation
A Phase 1 study testing AEB071 in people with de Novo Liver Transplantation, run by Novartis at 3 sites in 3 countries.
Trial summary
The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- de Novo Liver Transplantation
- What is being tested?
- AEB071
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2007to Feb 2009
- Phase
- Phase 1
- 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
- Primary liver transplant recipients.
- Transplanted liver functioning at an acceptable level by 24 h post-transplant
- Patients started on tacrolimus therapy within 12 h post-transplant
Who cannot join
- Previous transplantation or multiple organs transplantation
- Acute rejection
- Non-heart beating donor
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients
The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.
- Conditions
- de Novo Liver Transplantation
- Being tested
- AEB071
- Keywords
- Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AEB071 Receives: Drug: AEB071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Pharmacokinetic of AEB071 & its primary metabolite, AEE800 at predose & up to 72 hours post-operatively -Safety & tolerability (vital signs,ECGs,clinical lab evaluations,seroius/adverse events) -AEB071,AEE800 & tacrolimus in blood for both Periods
Measured: at predose & 16 timepoints post-dose
Secondary outcomes (1)
-Pharmacokinetics of tacrolimus in presence of AEB071 -Biliary excretion of AEB071 & primary metabolite (AEE800) from patients with a T-tube -Relationship of free drug concentration, α-1 acid glycoprotein concentration & pharmacokinetics AEB071
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for de Novo Liver TransplantationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545259
- Sponsor's protocol ID
- CAEB071B2101
- Status last verified
- Feb 2008
- First submitted
- 15 Oct 2007
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT00545259
- Acronym / sponsor ID
- CAEB071B2101
- Conditions
- de Novo Liver Transplantation
- Keywords
- Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (actual)
- First posted
- 17 Oct 2007 (estimated)
- 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.
The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AEB071AEB071 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary liver transplant recipients.
- Transplanted liver functioning at an acceptable level by 24 h post-transplant
- Patients started on tacrolimus therapy within 12 h post-transplant
Key exclusion criteria (4 listed)
- Previous transplantation or multiple organs transplantation
- Acute rejection
- Non-heart beating donor
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| AEB071 | Drug | 1 |
Primary outcome
-Pharmacokinetic of AEB071 & its primary metabolite, AEE800 at predose & up to 72 hours post-operatively -Safety & tolerability (vital signs,ECGs,clinical lab evaluations,seroius/adverse events) -AEB071,AEE800 & tacrolimus in blood for both Periods
Time frame: at predose & 16 timepoints post-dose
1 secondary outcome
-Pharmacokinetics of tacrolimus in presence of AEB071 -Biliary excretion of AEB071 & primary metabolite (AEE800) from patients with a T-tube -Relationship of free drug concentration, α-1 acid glycoprotein concentration & pharmacokinetics AEB071
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 8 Dec 2020.
- Results from CAEB071B2101 can be found on the Novartis Clinical Trial Results websiteLink provided by the sponsor.
Related trials for de Novo Liver Transplantation
RecruitingPhase 4
Extended-Release Tacrolimus Following Liver Transplantation
Liver Transplant; Complications, Renal Insufficiency
Not yet recruitingObservational study
Prevalence & Risk Factors of De Novo (MASLD) Post Liver Transplant
Post Liver Tranзplant
Active, not recruitingPhase 2
A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation
Liver Transplantation
RecruitingPhase 4
Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations
Liver Transplantation, Immunosuppression
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.
Novartis principal investigator
Investigator site
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AEB071 in people with de Novo Liver Transplantation, run by Novartis at 3 sites in 3 countries.
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 3 inclusion and 4 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy, Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
-Pharmacokinetic of AEB071 & its primary metabolite, AEE800 at predose & up to 72 hours post-operatively -Safety & tolerability (vital signs,ECGs,clinical lab evaluations,seroius/adverse events) -AEB071,AEE800 & tacrolimus in blood for both Periods (time frame: at predose & 16 timepoints post-dose). 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 8 Dec 2020.