Liver TransplantationPhase 2NCT00451932
A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients
A Phase 2 study testing FK778 in people with Liver Transplantation, run by Astellas Pharma Inc at 29 sites in 12 countries.
Trial summary
A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- FK778
- How many people
- 303 participants
- Where
- 29 sitesin 12 countries
- Study dates
- Oct 2002to Sep 2005
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients at least 18 years of age and not older than 65 years.
- Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
- Male patients must agree to practice effective birth control methods during the study.
- Patient is a recipient of a primary whole cadaveric liver transplant
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a liver.
- Patient has received an ABO incompatible donor liver.
- Patient or donor is known to be HIV positive.
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one > 3.0 cm.
- Patient has a serum creatinine >175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
- Patient who is receiving or may require warfarin or fluvastatin during the study.
- Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant
Trial locations and contacts
29 sites in 12 countries.
29 sites in 12 countries
France6 sites
Study site
Clichy
Study site
Lyon
Study site
Montpellier
Study site
Rennes
Study site
Strasbourg
Study site
Villejuif
Germany4 sites
Study site
Berlin
Study site
Essen
Study site
Hamburg
Study site
Hanover
Spain4 sites
Study site
Barakaldo
Study site
Barcelona
Study site
Madrid
Study site
Santiago de Compostela
Canada3 sites
Study site
Edmonton, Alberta
Study site
London, Ontario
Study site
Toronto, Ontario
About this study
Official title: A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy
A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.
- Conditions
- Liver Transplantation
- Being tested
- FK778
- Keywords
- Malononitrilamide, Immunosuppression, treatment efficacy, treatment effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK778Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of biopsy-proven acute rejections
Secondary outcomes (1)
Incidence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startOct 2002
- Primary completionSep 2005
- Study completionSep 2005
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
- Double blind
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Principal investigator, Universitätsklinik Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451932
- Sponsor's protocol ID
- FG-778-01-100
- Other IDs
- 8778-CL-1200
- Status last verified
- Apr 2008
- First submitted
- 23 Mar 2007
- Last updated
- 17 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy
- ClinicalTrials.gov ID
- NCT00451932
- Acronym / sponsor ID
- FG-778-01-100
- Conditions
- Liver Transplantation
- Keywords
- Malononitrilamide, Immunosuppression, treatment efficacy, treatment effectiveness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 26 Mar 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.
A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients at least 18 years of age and not older than 65 years.
- Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
- Male patients must agree to practice effective birth control methods during the study.
- Patient is a recipient of a primary whole cadaveric liver transplant
Key exclusion criteria (8 listed)
- Patient has previously received or is receiving an organ transplant other than a liver.
- Patient has received an ABO incompatible donor liver.
- Patient or donor is known to be HIV positive.
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one > 3.0 cm.
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 |
|---|---|---|
| FK778 | Drug | – |
Primary outcome
Event rate of biopsy-proven acute rejections
1 secondary outcome
Incidence of adverse events
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 17 Apr 2008.
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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.
Use Central Contact principal investigator
Universitätsklinik Charité
29 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK778 in people with Liver Transplantation, run by Astellas Pharma Inc at 29 sites in 12 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 4 inclusion and 8 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 17 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Germany, Spain, Canada, Belgium and 7 more countries. 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?
Event rate of biopsy-proven acute rejections. 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 17 Apr 2008.