Post Marketing Surveillance (PMS) Study of Cresemba in Korea.

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Prospective, 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

Conditions
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Aspergillosis, Mucormycosis

Intervention / Treatment
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* Drug: Isauvuconazole group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Isauvuconazole group|Patients who are treated with Isavuconazole according to its protocol label.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspergillosis, Mucormycosis, Isavuconazole, Korean