AspergillosisNCT04744454
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
An observational study of Aspergillosis and Mucormycosis, run by Pfizer at 1 site in South Korea.
Trial summary
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food and Drug Safety (MFDS). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aspergillosis, Mucormycosis
- What is being tested?
- Isauvuconazole group
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2021to 13 Jan 2026
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is performed in accordance with routine clinical practice as per regulatory requirement. Therefore, inclusion and exclusion criteria relate to the labelled indication and contraindications. (Refer to the most updated version of the local product document [LPD]) All patients initiated on Isavuconazole and provided informed consent to the study will be enrolled continuously up to the planned number of enrolled patients. The assignment of the patient to Isavuconazole is decided by the investigator if he/she considers administering as per the current practice would provide clinical benefit with regards to safety and effectiveness.
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients aged 19 years or older
- Patients with proven or suspected diagnosis of invasive Aspergillosis or invasive Mucormycosis.
- Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:
- Patients with known hypersensitivity to the active substance of Isavuconazole or to any of the excipients.
- Patients are ineligible as determined by the investigator, such as those with familial short QT syndrome.
- Patients administrating ketoconazole, high-dose ritonavir (>200 mg every 12 hours) or strong CYP3A4/5 inducers (e.g. rifampicin, carbamazepine, phenytoin) that cannot be discontinued before administration of Cresemba.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Cresemba to Evaluate Safety and Effectiveness in Patients With Invasive Aspergillosis or Invasive Mucormycosis in Korea.
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food and Drug Safety (MFDS).
Read the detailed description
In compliance with the Korean New Drug Re-Examination Guidelines, this study aims to collect further observational data on the safety and effectiveness of Cresemba for six years after authorization is obtained in at least 600 subjects under routine clinical practice. As the safety and effectiveness results obtained from the clinical development program of Cresemba are based on randomized trials using specific inclusion and exclusion criteria, data from the present post-authorization study where Cresemba is used in routine clinical practice per approved label is anticipated to provide important information on safety and effectiveness in a real-world population in Korea. This non-interventional study is designated as a PMS study and is a commitment to MFDS.
- Conditions
- Aspergillosis, Mucormycosis
- Being tested
- Isauvuconazole group
- Keywords
- Aspergillosis, Mucormycosis, Isavuconazole, Korean
- Medical subject headings
- Aspergillosis, Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isauvuconazole groupDrug
Patients who are treated with Isavuconazole according to its protocol label.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) as safety evaluation
Incidence of the adverse events from baseline in all patients who received at least one dose of Isavuconazole and completed safety follow up will be assessed. AEs will be analyzed by preferred term coding.
Measured: Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole.
Secondary outcomes (1)
Effectiveness evaluation
Effectiveness parameters- clinical response will be evaluated.
Measured: From baseline to end of treatment or up to 12 weeks, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start28 Oct 2021
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744454
- Sponsor's protocol ID
- C3791006
- Other IDs
- NCT04744454
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Cresemba to Evaluate Safety and Effectiveness in Patients With Invasive Aspergillosis or Invasive Mucormycosis in Korea.
- ClinicalTrials.gov ID
- NCT04744454
- Acronym / sponsor ID
- C3791006
- Conditions
- Aspergillosis, Mucormycosis
- Keywords
- Aspergillosis, Mucormycosis, Isavuconazole, Korean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 9 Feb 2021 (actual)
- 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 observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food and Drug Safety (MFDS).
Detailed description
In compliance with the Korean New Drug Re-Examination Guidelines, this study aims to collect further observational data on the safety and effectiveness of Cresemba for six years after authorization is obtained in at least 600 subjects under routine clinical practice. As the safety and effectiveness results obtained from the clinical development program of Cresemba are based on randomized trials using specific inclusion and exclusion criteria, data from the present post-authorization study where Cresemba is used in routine clinical practice per approved label is anticipated to provide important information on safety and effectiveness in a real-world population in Korea. This non-interventional study is designated as a PMS study and is a commitment to MFDS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is performed in accordance with routine clinical practice as per regulatory requirement. Therefore, inclusion and exclusion criteria relate to the labelled indication and contraindications. (Refer to the most updated version of the local product document [LPD]) All patients initiated on Isavuconazole and provided informed consent to the study will be enrolled continuously up to the planned number of enrolled patients. The assignment of the patient to Isavuconazole is decided by the investigator if he/she considers administering as per the current practice would provide clinical benefit with regards to safety and effectiveness.
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 |
|---|---|---|
| Isauvuconazole groupPatients who are treated with Isavuconazole according to its protocol label. | Drug | – |
Primary outcome
Adverse event (AE) as safety evaluation
Time frame: Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole.
Incidence of the adverse events from baseline in all patients who received at least one dose of Isavuconazole and completed safety follow up will be assessed. AEs will be analyzed by preferred term coding.
1 secondary outcome
Effectiveness evaluation
Time frame: From baseline to end of treatment or up to 12 weeks, whichever comes first.
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 13 Apr 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspergillosis and Mucormycosis, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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?
Adverse event (AE) as safety evaluation (time frame: Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole.). 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 13 Apr 2026.