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| ID | Type | Description | Link |
|---|---|---|---|
| NCT04744454 | Registry Identifier | ClinicalTrials.gov |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isauvuconazole group | Drug | Patients who are treated with Isavuconazole according to its protocol label. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness evaluation | Effectiveness parameters- clinical response will be evaluated. | From baseline to end of treatment or up to 12 weeks, whichever comes first. |
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Korea | Seoul | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D009091 | Mucormycosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020096 | Zygomycosis |
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