FungemiaPhase 3NCT00794703
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
A Phase 3 study testing micafungin (Mycamine) and itraconazole in people with Fungemia and Fungal Infections, run by Astellas Pharma Inc at 10 sites in China.
Trial summary
The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fungemia, Fungal Infections
- What is being tested?
- micafungin (Mycamine) and itraconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 10 sitesChina
- Study dates
- Nov 2008to Nov 2009
- Phase
- Phase 3
- 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
- Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
- Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant
- Any patient undergoing an allogeneic hematopoietic stem cell transplant
Who cannot join
- Patients with moderate or severe liver disease, as defined by:
- AST or ALT greater than 5 times upper limit of normal (ULN), OR;
- Total bilirubin greater than 2.5 times ULN
- Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Study site
Beijing
Study site
Chengdu, Sichuan
Study site
Fuzhou, Fujian
Study site
Hangzhou, Zhejiang
Study site
Jiangsu
Study site
Nanning
Study site
Shanghai
Study site
Tianjin
Study site
Wuhan, Hubei
Study site
Xi'an
About this study
Official title: A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant
The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients
Read the detailed description
Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days
- Conditions
- Fungemia, Fungal Infections
- Being tested
- micafungin (Mycamine), itraconazole
- Keywords
- Antifungal, micafungin, itraconazole
- Medical subject headings
- Fungemia, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micafungin (Mycamine)Drug
Also called Mycamine, FK463
Intravenous
itraconazoleDrug
Also called Sporanox
oral
| Study group | Role | What they receive |
|---|---|---|
| 1. Micafungin | Experimental | Not described Receives: Drug: micafungin (Mycamine) |
| 2. Itraconazole | Active comparator | Not described Receives: Drug: itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate (fungal breakthrough rate)
Measured: At the end of the study
Secondary outcomes (4)
Incidence of proven or probable invasive fungal infection
Measured: Throughout the study period
The usage rate of systemic antifungal agents
Measured: During 4 weeks after the administration
Time to treatment failure
Measured: During the study period
Assessment of Adverse events, Laboratory examinations and vital signs evaluation
Measured: Throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FungemiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794703
- Sponsor's protocol ID
- MCFGCN02-0
- Status last verified
- Mar 2016
- First submitted
- 19 Nov 2008
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Huang X, Chen H, Han M, Zou P, Wu D, Lai Y, Huang H, Chen X, Liu T, Zhu H, Wang J, Hu J. Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2012 Oct;18(10):1509-16. doi: 10.1016/j.bbmt.2012.03.014. Epub 2012 Mar 30.
PubMed 22469884
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00794703
- Acronym / sponsor ID
- MCFGCN02-0
- Conditions
- Fungemia, Fungal Infections
- Keywords
- Antifungal, micafungin, itraconazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Nov 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.
The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients
Detailed description
Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Micafungin | Experimental | Drug: micafungin (Mycamine) |
| 2. Itraconazole | Active comparator | Drug: itraconazole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
Key exclusion criteria (4 listed)
- Patients with moderate or severe liver disease, as defined by:
- Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment
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 |
|---|---|---|
| micafungin (Mycamine)Also: Mycamine, FK463Intravenous | Drug | 1. Micafungin |
| itraconazoleAlso: Sporanoxoral | Drug | 2. Itraconazole |
Primary outcome
Treatment success rate (fungal breakthrough rate)
Time frame: At the end of the study
4 secondary outcomes
Incidence of proven or probable invasive fungal infection
Time frame: Throughout the study period
The usage rate of systemic antifungal agents
Time frame: During 4 weeks after the administration
Time to treatment failure
Time frame: During the study period
Assessment of Adverse events, Laboratory examinations and vital signs evaluation
Time frame: Throughout the study period
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 28 Mar 2016.
- Derived from this study: PubMed 22469884Huang X, Chen H, Han M, Zou P, Wu D, Lai Y, Huang H, Chen X, Liu T, Zhu H, Wang J, Hu J. Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2012 Oct;18(10):1509-16. doi: 10.1016/j.bbmt.2012.03.014. Epub 2012 Mar 30.
- Individual participant dataSharing planned: Undecided
Related trials for Fungemia
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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 study chair
Astellas Pharma Inc
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing micafungin (Mycamine) and itraconazole in people with Fungemia and Fungal Infections, run by Astellas Pharma Inc at 10 sites in China.
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 3 inclusion and 4 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Treatment success rate (fungal breakthrough rate) (time frame: At the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794703, which also lists 1 linked publication.
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 Mar 2016.