AspergillosisPhase 2NCT00036166
Study of FK463 for the Treatment of Invasive Aspergillosis
A Phase 2 study testing FK463 in people with Aspergillosis, run by Astellas Pharma Inc at 23 sites in 8 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspergillosis
- What is being tested?
- FK463
- How many people
- 326 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 29 Jan 1999to 31 Jan 2002
- 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
- Has proven or probable systemic infection with Aspergillus species
Who cannot join
- Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
- Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion
- Has life-expectancy judged to be less than 5 days
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Germany7 sites
Johann Wolfgang Goethe Universitat, Medizinische Klinik III
Frankfurt, D-60590
Westpfalz Krankehaus
Kaiserslautern, D-67655
Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
Leipzig, D-04103
Klinikum der Stadt, Medizinische Klinik A
Ludwigshafen, D-67063
Uniklinik Mainz
Mainz, 55101
LMU Munchen, Hamatopoetische Zell - Transplantation
München, D-81366
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
Würzburg, E-97070
France4 sites
Hopital Henri Mondor, Service d'Hematologie Clinique
Créteil, 94010
Hotel Dieu, Service d'Hematologie
Nantes, 44093
Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
Paris, 10
Hopital Necker Enfants Malades, Service d'Hematologie
Paris, 75015
Spain3 sites
Hospital Clinic I provencial, Servicio Enfermadades Infecciosas
Barcelona, ES 28041
Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
Madrid, ES 28007
Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas
Madrid, ES 28041
United Kingdom3 sites
Royal Free Hospital, Dept. of Haematological Oncology
London, NW3 2QG
Christie Hospital NHS Trust
Manchester, M20 4BX
Royal Marsden Hospital
Sutton Surrey, SM2 5PT
Austria2 sites
Medizinische Univ.-Klinik
Graz, 8036
Krankenhaus Elisabethinen Linz
Linz, A-4010
Italy2 sites
Nationale Institute for Cancer Research
Genova, I 16132
Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
Milan, 20162
Sweden1 site
Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
Huddinge, SE141 86
About this study
Official title: An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis
The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.
Read the detailed description
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
- Conditions
- Aspergillosis
- Being tested
- FK463
- Keywords
- Aspergillus, Anti-Fungal
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK463Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study start29 Jan 1999
- Primary completion31 Jan 2002
- Study completion31 Jan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036166
- Sponsor's protocol ID
- FG463-21-01
- Other IDs
- 98-0-046
- Status last verified
- Jun 2015
- First submitted
- 8 May 2002
- Last updated
- 10 Jan 2018
- Results posted
- No
Publications
Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.
PubMed 16678903Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdiere M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.
PubMed 18983417
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis
- ClinicalTrials.gov ID
- NCT00036166
- Acronym / sponsor ID
- FG463-21-01
- Conditions
- Aspergillosis
- Keywords
- Aspergillus, Anti-Fungal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 1999 (actual)
- Primary completion
- 31 Jan 2002 (actual)
- Study completion
- 31 Jan 2002 (actual)
- First posted
- 9 May 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 the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.
Detailed description
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has proven or probable systemic infection with Aspergillus species
Key exclusion criteria (3 listed)
- Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
- Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion
- Has life-expectancy judged to be less than 5 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 |
|---|---|---|
| FK463 | 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 10 Jan 2018.
- Results publication: PubMed 16678903Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.
- Results publication: PubMed 18983417Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdiere M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK463 in people with Aspergillosis, run by Astellas Pharma Inc at 23 sites in 8 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 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: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, France, Spain, United Kingdom, Austria and 3 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 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?
On the ClinicalTrials.gov record for NCT00036166, which also lists 2 linked publications.
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 10 Jan 2018.