Liver TransplantationPhase 2TASTNCT00693524
Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX
A Phase 2 study testing tacrolimus, Anti-IL2R AB and Mycophenolate mofetil in people with Liver Transplantation, run by Astellas Pharma Inc at 8 sites in Italy.
Trial summary
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen 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?
- tacrolimus, Anti-IL2R AB and Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 8 sitesItaly
- Study dates
- Nov 2002to Mar 2004
- Phase
- Phase 2
- 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
- Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years
Who cannot join
- Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
- Recipient of an auxiliary graft or in which a bio-artificial liver has been used
- Patient is receiving a living related liver transplantation
- Patient is requiring steroids as well as chemotherapy prior to transplantation
- Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:
- > 3 nodes
Show all 9Show fewer
- No node larger than 5 cm
- No metastases
- No vascular invasion
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Study site
Bologna
Study site
Genova
Study site
Milan
Study site
Naples
Study site
Padova
Study site
Roma
Study site
Torino
Study site
Udine
About this study
Official title: An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver Allograft Transplantation
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen
- Conditions
- Liver Transplantation
- Being tested
- tacrolimus, Anti-IL2R AB, Mycophenolate mofetil, prednisone
- Keywords
- liver allograft transplantation, sequential therapy, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called FK506, Prograf
oral
Anti-IL2R ABDrug
Also called daclizumab
i.v.
oral
prednisoneDrug
Also called steroid
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil Receives: Drug: tacrolimus; Drug: Anti-IL2R AB; Drug: Mycophenolate mofetil |
| 2 | Active comparator | Tacrolimus + Steroid Receives: Drug: tacrolimus; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first acute rejection
Measured: 3 months
Secondary outcomes (1)
Overall frequences of acute rejection episodes
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startNov 2002
- Primary completionMar 2004
- Study completionMar 2004
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693524
- Sponsor's protocol ID
- FG-506-01-IT-01
- Acronym
- TAST
- Status last verified
- Aug 2014
- First submitted
- 4 Jun 2008
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver Allograft Transplantation
- ClinicalTrials.gov ID
- NCT00693524
- Acronym / sponsor ID
- TAST / FG-506-01-IT-01
- Conditions
- Liver Transplantation
- Keywords
- liver allograft transplantation, sequential therapy, tacrolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 9 Jun 2008 (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.
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tacrolimus, Drug: Anti-IL2R AB, Drug: Mycophenolate mofetilTacrolimus + Anti-IL2R AB + Mycophenolate mofetil |
| 2 | Active comparator | Drug: tacrolimus, Drug: prednisoneTacrolimus + Steroid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years
Key exclusion criteria (9 listed)
- Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
- Recipient of an auxiliary graft or in which a bio-artificial liver has been used
- Patient is receiving a living related liver transplantation
- Patient is requiring steroids as well as chemotherapy prior to transplantation
- Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:
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 |
|---|---|---|
| tacrolimusAlso: FK506, Prograforal | Drug | 1, 2 |
| Anti-IL2R ABAlso: daclizumabi.v. | Drug | 1 |
| Mycophenolate mofetiloral | Drug | 1 |
| prednisoneAlso: steroidoral | Drug | 2 |
Primary outcome
Incidence of first acute rejection
Time frame: 3 months
1 secondary outcome
Overall frequences of acute rejection episodes
Time frame: 3 months
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 26 Aug 2014.
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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.
Central Contact study director
Astellas Pharma Europe B.V.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tacrolimus, Anti-IL2R AB and Mycophenolate mofetil in people with Liver Transplantation, run by Astellas Pharma Inc at 8 sites in Italy.
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 1 inclusion and 9 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 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of first acute rejection (time frame: 3 months). 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 26 Aug 2014.