Bone Marrow TransplantationPhase 2NCT00189748
A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-
A Phase 2 study testing Tacrolimus in people with Bone Marrow Transplantation and Graft Versus Host Disease, run by Astellas Pharma Inc at 4 sites in Japan.
Trial summary
To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year) Read more about this study
- Who is it for?
- Ages 20 to 54 years
- Conditions the study is for
- Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-Host Disease
- What is being tested?
- Tacrolimus
- How many people
- Not given
- Where
- 4 sitesJapan
- Study dates
- Aug 2004to not given
- 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 20 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient had enrolled in GVHD prophylaxis study.
- Patient had been fully informed.
Who cannot join
- The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Chubu Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kyusyu Region
About this study
Official title: An Extension Study of the Patients Enrolled in Acute Graft Versus Host Disease (GVHD) Prophylaxis Study (Protocol No. FJ-506E-BT01) to Assess Safety and Efficacy of GVHD Prophylaxis of a Tacrolimus New Oral Formulation (MR4).
To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)
- Conditions
- Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-Host Disease, Graft-Vs-Host Disease
- Being tested
- Tacrolimus
- Keywords
- Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical development, Study chair, Astellas Pharma Inc., Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189748
- Sponsor's protocol ID
- FJ-506E-BT02
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of the Patients Enrolled in Acute Graft Versus Host Disease (GVHD) Prophylaxis Study (Protocol No. FJ-506E-BT01) to Assess Safety and Efficacy of GVHD Prophylaxis of a Tacrolimus New Oral Formulation (MR4).
- ClinicalTrials.gov ID
- NCT00189748
- Acronym / sponsor ID
- FJ-506E-BT02
- Conditions
- Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-Host Disease, Graft-Vs-Host Disease
- Keywords
- Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- First posted
- 19 Sep 2005 (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 assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient had enrolled in GVHD prophylaxis study.
- Patient had been fully informed.
Key exclusion criteria (1 listed)
- The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.
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 |
|---|---|---|
| Tacrolimus | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Sep 2006.
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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.
Clinical development study chair
Astellas Pharma Inc., Japan
4 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 in people with Bone Marrow Transplantation and Graft Versus Host Disease, run by Astellas Pharma Inc at 4 sites in Japan.
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 2 inclusion and 1 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 20 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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.
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 20 Sep 2006.