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

Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744454
• Other study ID #: C3791006
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Aspergillosis
• Mucormycosis
• Zygomycosis

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.

External Links

•   To obtain contact information for a study center near you, click here.