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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04744454
Other study ID # C3791006
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 28, 2021
Est. completion date January 30, 2026

Study information

Verified date March 2023
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date January 30, 2026
Est. primary completion date January 30, 2026
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Isauvuconazole group
Patients who are treated with Isavuconazole according to its protocol label.

Locations

Country Name City State
Korea, Republic of Pfizer Korea Seoul

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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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