Liver TransplantationPhase 4NCT01018914
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
A Phase 4 study testing Prograf, Advagraf and Myfortic in people with Liver Transplantation, run by Astellas Pharma Inc at 3 sites in Taiwan.
Trial summary
To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Prograf, Advagraf and Myfortic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesTaiwan
- Study dates
- Apr 2009to Dec 2010
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a primary liver transplant recipient
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- Patient must receive 1st dose of study drug within 24 hours of pre-transplantation
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a liver
- Patient currently requires dialysis
- Patient has received a liver transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor liver
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- Patient has fulminant hepatic failure, unless hemodynamically stable
Show all 10Show fewer
- Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
- Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
- Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
- Patient is pregnant or lactating
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients
To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.
- Conditions
- Liver Transplantation
- Being tested
- Prograf, Advagraf, Myfortic
- Keywords
- Prograf, Advagraf, Myfortic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrografDrug
Also called Tacrolimus, FK506
oral
AdvagrafDrug
Also called Extended release tacrolimus, FK506E, MR4
oral
MyforticDrug
Also called Mycophenolate sodium
oral
| Study group | Role | What they receive |
|---|---|---|
| Prograf with Myfortic | Active comparator | Not described Receives: Drug: Prograf; Drug: Myfortic |
| Advagraf with Myfortic | Experimental | Not described Receives: Drug: Advagraf; Drug: Myfortic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy confirmed acute rejection
Measured: during the 6 months post-transplant.
Secondary outcomes (4)
Patient and graft survival rates
Measured: during the 6 months post-transplant
Time to first biopsy confirmed acute rejection episode
Measured: during the 6 months post-transplant
Incidence of anti-lymphocyte antibody therapy for treatment of rejection
Measured: during the 6 months post-transplant.
Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018914
- Sponsor's protocol ID
- ADVLTx-0901-TW
- Status last verified
- Jan 2016
- First submitted
- 23 Nov 2009
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01018914
- Acronym / sponsor ID
- ADVLTx-0901-TW
- Conditions
- Liver Transplantation
- Keywords
- Prograf, Advagraf, Myfortic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Nov 2009 (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.
To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prograf with Myfortic | Active comparator | Drug: Prograf, Drug: Myfortic |
| Advagraf with Myfortic | Experimental | Drug: Advagraf, Drug: Myfortic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is a primary liver transplant recipient
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- Patient must receive 1st dose of study drug within 24 hours of pre-transplantation
Key exclusion criteria (10 listed)
- Patient has previously received or is receiving an organ transplant other than a liver
- Patient currently requires dialysis
- Patient has received a liver transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor liver
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
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 |
|---|---|---|
| PrografAlso: Tacrolimus, FK506oral | Drug | Prograf with Myfortic |
| AdvagrafAlso: Extended release tacrolimus, FK506E, MR4oral | Drug | Advagraf with Myfortic |
| MyforticAlso: Mycophenolate sodiumoral | Drug | Advagraf with Myfortic, Prograf with Myfortic |
Primary outcome
Incidence of biopsy confirmed acute rejection
Time frame: during the 6 months post-transplant.
4 secondary outcomes
Patient and graft survival rates
Time frame: during the 6 months post-transplant
Time to first biopsy confirmed acute rejection episode
Time frame: during the 6 months post-transplant
Incidence of anti-lymphocyte antibody therapy for treatment of rejection
Time frame: during the 6 months post-transplant.
Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs
Time frame: throughout the study
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 29 Jan 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
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 study chair
Astellas Pharma Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prograf, Advagraf and Myfortic in people with Liver Transplantation, run by Astellas Pharma Inc at 3 sites in Taiwan.
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 10 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 29 Jan 2016. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 biopsy confirmed acute rejection (time frame: during the 6 months post-transplant.). 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 29 Jan 2016.