Invasive AspergillosisPhase 4NCT02646774
Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
A Phase 4 study testing Micafungin in people with Invasive Aspergillosis, run by Astellas Pharma China, Inc. at 19 sites in China.
Trial summary
The objective of this study is to evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by Aspergillus sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 19 sitesChina
- Study dates
- 1 Mar 2014to 26 Jun 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of EORTC/MSG
- Females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study.
- Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
Who cannot join
- Patient received any echinocandins drug within 1 month prior to enrollment.
- Patient was enrolled in any other clinical study within the last month.
- AST/ALT > 5 times the upper limit of normal (ULN)
- total bilirubin> 2.5 times ULN
- BUN/Ccr > 3 times ULN
- HIV positive patient
Show all 11Show fewer
- Patient has a history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins.
- Patient has a life expectancy of <1 month
- Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
- Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study.
- Patient has been previously enrolled in this study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Study site
Beijing
Study site
Changsha
Study site
Chengdu
Study site
Fuzhou
Study site
Guangzhou
Study site
Hangzhou
Study site
Harbin
Study site
Hefei
Study site
Hengyang
Study site
Jinan
Study site
Nanchan
Study site
Shanghai
Study site
Shijiazhuang
Study site
Suzhou
Study site
Taiyuan
Study site
Tianjing
Study site
Wenzhou
Study site
Wuhan
Study site
Zhengzhou
About this study
Official title: A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)
The objective of this study is to evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by Aspergillus sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
- Conditions
- Invasive Aspergillosis
- Being tested
- Micafungin
- Keywords
- Aspergillosis, Antifungal, 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
Injection
| Study group | Role | What they receive |
|---|---|---|
| Micafungin group | Experimental | Injection Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate for patients with no hematology disease
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Measured: At the end of the treatment (up to a maximum of 4 weeks)
Overall success rate for patients with hematology disease
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Measured: At the end of the treatment (up to a maximum of 12 weeks)
Secondary outcomes (8)
Clinical improvement rate for patients with no hematology disease
Measured: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Clinical Improvement rate for patients with hematology disease
Measured: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fungal clearance rate for patients with no hematology disease
Measured: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Fungal clearance rate for patients with hematology disease
Measured: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fatality rate for patients with no hematology disease
Measured: End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients)
Fatality rate for patients with hematology disease
Measured: End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Percentage of participants with common Aspergillus infection sites
Measured: End of treatment (up to 12 weeks)
Safety assessed by adverse events
Measured: Up to 2 weeks after end of treatment (up to14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start1 Mar 2014
- Primary completion26 Jun 2015
- Study completion26 Jun 2015
Why it stopped: Due to administrative reasons
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646774
- Sponsor's protocol ID
- ACN-MA-MYC-IA-2012
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2015
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)
- ClinicalTrials.gov ID
- NCT02646774
- Acronym / sponsor ID
- ACN-MA-MYC-IA-2012
- Conditions
- Invasive Aspergillosis
- Keywords
- Aspergillosis, Antifungal, Micafungin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to administrative reasons
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 26 Jun 2015 (actual)
- Study completion
- 26 Jun 2015 (actual)
- First posted
- 6 Jan 2016 (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 evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by Aspergillus sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micafungin group | Experimental | Drug: MicafunginInjection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of EORTC/MSG
- Females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study.
- Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
Key exclusion criteria (11 listed)
- Patient received any echinocandins drug within 1 month prior to enrollment.
- Patient was enrolled in any other clinical study within the last month.
- AST/ALT > 5 times the upper limit of normal (ULN)
- total bilirubin> 2.5 times ULN
- BUN/Ccr > 3 times ULN
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 |
|---|---|---|
| MicafunginInjection | Drug | Micafungin group |
Primary outcome
Overall success rate for patients with no hematology disease
Time frame: At the end of the treatment (up to a maximum of 4 weeks)
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Overall success rate for patients with hematology disease
Time frame: At the end of the treatment (up to a maximum of 12 weeks)
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
8 secondary outcomes
Clinical improvement rate for patients with no hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Clinical Improvement rate for patients with hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fungal clearance rate for patients with no hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Fungal clearance rate for patients with hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fatality rate for patients with no hematology disease
Time frame: End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients)
Fatality rate for patients with hematology disease
Time frame: End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Percentage of participants with common Aspergillus infection sites
Time frame: End of treatment (up to 12 weeks)
Safety assessed by adverse events
Time frame: Up to 2 weeks after end of treatment (up to14 weeks)
Results and safety
The study was stopped early (reason given: Due to administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
19 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 Invasive Aspergillosis, run by Astellas Pharma China, Inc. at 19 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 11 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 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 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?
The study was stopped early (reason given: Due to administrative reasons). 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?
Overall success rate for patients with no hematology disease (time frame: At the end of the treatment (up to a maximum of 4 weeks)). The study lists 2 primary outcomes in all. 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 Nov 2024.