Invasive AspergillosisPhase 2NCT00376337
Micafungin Salvage Mono-therapy in Invasive Aspergillosis
A Phase 2 study testing Micafungin and Systemic antifungal therapy in people with Invasive Aspergillosis, run by Astellas Pharma Inc at 46 sites in 12 countries.
Trial summary
To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- Micafungin and Systemic antifungal therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 46 sitesin 12 countries
- Study dates
- Jun 2006to Sep 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with HSCT, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin B or voriconazole products
Who cannot join
- Patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection
Trial locations and contacts
46 sites in 12 countries.
46 sites in 12 countries
Brazil10 sites
Study site
Belo Horizonte
Study site
Campinas
Study site
Curitiba
Study site
Goiânia
Study site
Ipatinga
Study site
Porto Alegre
Study site
Ribeirão Preto
Study site
Rio de Janeiro
Study site
Santo André
Study site
São Paulo
France5 sites
Study site
Bobigny
Study site
Dijon, 21034
Study site
Dijon
Study site
Paris
Study site
Pessac
Germany5 sites
Study site
Berlin
Study site
Bonn
Study site
Munich
Study site
Münster
Study site
Würzburg
Belgium4 sites
Study site
Aalst, 9300
Study site
Brussels
Study site
Ghent
Study site
Leuven, 3000
Czechia4 sites
Study site
Hradec Králové
Study site
Olomouc, 77520
Study site
Prague, 12820
Study site
Prague
Spain4 sites
Study site
Madrid, 28034
Study site
Madrid, 28046
Study site
Salamanca
Study site
Seville
About this study
Official title: A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis
To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm
Read the detailed description
This is a phase II, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study.
Patients will be stratified according to the baseline infection status and the baseline neutropenic status:
- Intolerant to previous antifungal therapy
- Refractory to previous antifungal therapy; progression of infection
- Refractory to previous antifungal therapy; failure to improve In case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory.
- Neutropenic (absolute neutrophil count (ANC < 500 cells/mm3)
- Non neutropenic (ANC >= 500 cells/mm3)
- Conditions
- Invasive Aspergillosis
- Being tested
- Micafungin, Systemic antifungal therapy
- Keywords
- Invasive Aspergillosis, Salvage Therapy, Micafungin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called FK463
IV
Systemic antifungal therapyDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | infusion for 3-12 weeks Receives: Drug: Systemic antifungal therapy |
| 2 | Experimental | infusion for 3-12 weeks Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.
Measured: Weeks 3-12
Secondary outcomes (1)
Overall success at end of treatment
Measured: Weeks 3-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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 Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376337
- Sponsor's protocol ID
- FG463-21-20
- Status last verified
- Oct 2011
- First submitted
- 13 Sep 2006
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis
- ClinicalTrials.gov ID
- NCT00376337
- Acronym / sponsor ID
- FG463-21-20
- Conditions
- Invasive Aspergillosis
- Keywords
- Invasive Aspergillosis, Salvage Therapy, Micafungin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Sep 2006 (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 evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm
Detailed description
This is a phase II, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study.
Patients will be stratified according to the baseline infection status and the baseline neutropenic status:
- Intolerant to previous antifungal therapy
- Refractory to previous antifungal therapy; progression of infection
- Refractory to previous antifungal therapy; failure to improve In case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory.
- Neutropenic (absolute neutrophil count (ANC < 500 cells/mm3)
- Non neutropenic (ANC >= 500 cells/mm3)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Systemic antifungal therapyinfusion for 3-12 weeks |
| 2 | Experimental | Drug: Micafungininfusion for 3-12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with HSCT, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin B or voriconazole products
Key exclusion criteria (1 listed)
- Patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection
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: FK463IV | Drug | 2 |
| Systemic antifungal therapyIV | Drug | 1 |
Primary outcome
Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.
Time frame: Weeks 3-12
1 secondary outcome
Overall success at end of treatment
Time frame: Weeks 3-12
Results and safety
The study was stopped early (reason given: Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Link to FDA websiteLink provided by the sponsor.
Related trials for Invasive Aspergillosis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
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Fungal Status and Prognosis in ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
RecruitingObservational study
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
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Active, not recruitingObservational study
Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors
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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 Europe B.V.
46 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micafungin and Systemic antifungal therapy in people with Invasive Aspergillosis, run by Astellas Pharma Inc at 46 sites in 12 countries.
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 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: stopped early, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Brazil, France, Germany, Belgium, Czechia and 7 more countries. 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: Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis). 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?
Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response. (time frame: Weeks 3-12). 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 5 Sep 2013.