AspergillosisPhase 2NCT00047827
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
A Phase 2 study testing Micafungin and Liposomal Amphotericin B in people with Aspergillosis, run by Astellas Pharma Inc at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aspergillosis
- What is being tested?
- Micafungin and Liposomal Amphotericin B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2002to Feb 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy
Who cannot join
- Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
- Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion
- Has life expectancy of less than five days
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30322
Study site
Detroit, Michigan, 48201
Study site
Houston, Texas, 77030
Study site
Memphis, Tennessee, 38105
Study site
St Louis, Missouri, 63110
Study site
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis
The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
- Conditions
- Aspergillosis
- Being tested
- Micafungin, Liposomal Amphotericin B
- Keywords
- Aspergillus, Aspergillosis, Anti-Fungal, AmBisome, Micafungin
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called Mycamine, FK463
IV
Liposomal Amphotericin BDrug
Also called AmBisome
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Micafungin; Drug: Liposomal Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment response defined as complete or partial response
Measured: Day 28, end of combined therapy and Day 84
Secondary outcomes (4)
Clinical Response
Measured: Day 28, end of combined therapy and Day 84
Radiological Response
Measured: Day 28, end of combined therapy and Day 84
Mycological Response
Measured: Day 28, end of combined therapy and Day 84
Survival at Day 84
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2002 (estimated)
- Study startDec 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047827
- Sponsor's protocol ID
- 01-0-125
- Other IDs
- FG463-21-11
- Status last verified
- Aug 2014
- First submitted
- 18 Oct 2002
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis
- ClinicalTrials.gov ID
- NCT00047827
- Acronym / sponsor ID
- 01-0-125
- Conditions
- Aspergillosis
- Keywords
- Aspergillus, Aspergillosis, Anti-Fungal, AmBisome, Micafungin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 24 Oct 2002 (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 purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Micafungin, Drug: Liposomal Amphotericin B |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy
Key exclusion criteria (3 listed)
- Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
- Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion
- Has life expectancy of less than five days
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: Mycamine, FK463IV | Drug | 1 |
| Liposomal Amphotericin BAlso: AmBisomeIV | Drug | 1 |
Primary outcome
Incidence of treatment response defined as complete or partial response
Time frame: Day 28, end of combined therapy and Day 84
4 secondary outcomes
Clinical Response
Time frame: Day 28, end of combined therapy and Day 84
Radiological Response
Time frame: Day 28, end of combined therapy and Day 84
Mycological Response
Time frame: Day 28, end of combined therapy and Day 84
Survival at Day 84
Time frame: Day 84
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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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.
Central Contact study director
Astellas Pharma US, Inc.
7 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 Micafungin and Liposomal Amphotericin B in people with Aspergillosis, run by Astellas Pharma Inc at 7 sites in United States.
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 3 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: stopped early, as of the sponsor's last update on 20 Aug 2014. 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 United States. 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 was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
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 treatment response defined as complete or partial response (time frame: Day 28, end of combined therapy and Day 84). 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 20 Aug 2014.