Status:
RECRUITING
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
Lead Sponsor:
Pfizer
Conditions:
Aspergillosis
Mucormycosis
Eligibility:
All Genders
19+ years
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04744454
Start Date
October 28 2021
End Date
January 30 2026
Last Update
June 17 2025
Active Locations (1)
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1
Pfizer Korea
Seoul, South Korea