NeutropeniaPhase 4NCT01135589
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
A Phase 4 study testing Micafungin in people with Neutropenia and Hematopoietic Stem Cell Transplantation, run by Asan Medical Center at 7 sites in South Korea.
Trial summary
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Neutropenia, Hematopoietic Stem Cell Transplantation, Invasive Fungal Disease
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Apr 2010to May 2012
- 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 Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients will receive allogeneic hematopoietic stem cell transplantation
Who cannot join
- Aspartate transaminase or alanine transaminase level > 5 times UNL
- Bilirubin > 2. 5 times UNL
- History of allergy, sensitivity, or any serious reaction to an echinocandin
- Invasive fungal disease at the time of enrolment
- Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
- Positive pregnancy test
Trial locations and contacts
7 sites in 1 country.
Clinical Development Administration Dept. contact
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Study site
Busan
- Recruiting
Study site
Daegu
- Recruiting
Study site
Daejeon
- Recruiting
Study site
Goyang
- Recruiting
Study site
Hwasun
- Recruiting
Study site
Seoul
- Recruiting
Study site
Suwon
About this study
Official title: Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
Read the detailed description
The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after allogeneic hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.
- Being tested
- Micafungin
- Keywords
- pediatric, adolescent, micafungin
- Medical subject headings
- Neutropenia, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called FK463, Fungard
i.v.
| Study group | Role | What they receive |
|---|---|---|
| HSCT | Experimental | Not described Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence rate of IFDs assessed by physical examination and serum galactomannan test
Measured: during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis
Secondary outcomes (2)
Survival rate
Measured: at day 100
Safety assessed by lab-test and adverse events
Measured: during micafungin prophylaxis therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135589
- Sponsor's protocol ID
- KSPHO 2010-02
- Status last verified
- Jun 2010
- First submitted
- 25 May 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01135589
- Acronym / sponsor ID
- KSPHO 2010-02
- Keywords
- pediatric, adolescent, micafungin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Apr 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 3 Jun 2010 (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.
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
Detailed description
The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after allogeneic hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSCT | Experimental | Drug: Micafungin |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients will receive allogeneic hematopoietic stem cell transplantation
Key exclusion criteria (6 listed)
- Aspartate transaminase or alanine transaminase level > 5 times UNL
- Bilirubin > 2. 5 times UNL
- History of allergy, sensitivity, or any serious reaction to an echinocandin
- Invasive fungal disease at the time of enrolment
- Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
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 |
|---|---|---|
| MicafunginAlso: FK463, Fungardi.v. | Drug | HSCT |
Primary outcome
Absence rate of IFDs assessed by physical examination and serum galactomannan test
Time frame: during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis
2 secondary outcomes
Survival rate
Time frame: at day 100
Safety assessed by lab-test and adverse events
Time frame: during micafungin prophylaxis therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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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 Administration Dept. contact
Use Central Contact study chair
Astellas Pharma Inc
7 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 Micafungin in people with Neutropenia and Hematopoietic Stem Cell Transplantation, run by Asan Medical Center at 7 sites in South Korea.
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 6 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: status not confirmed, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development Administration Dept. (clinicaltrials_info@jp.astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence rate of IFDs assessed by physical examination and serum galactomannan test (time frame: during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis). 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 28 Sep 2010.