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

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04744454

Collaborator

(none)

600

Enrollment

Location

52.7

Anticipated Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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 required by Ministry of Food and Drug Safety (MFDS).

Condition or Disease	Intervention/Treatment	Phase
Aspergillosis Mucormycosis	Drug: Isauvuconazole group

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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 9, 2021

Anticipated Primary Completion Date :

Jan 30, 2026

Anticipated Study Completion Date :

Jan 30, 2026

Outcome Measures

Primary Outcome Measures

Adverse event (AE) as safety evaluation [Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole.]
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.

Secondary Outcome Measures

Effectiveness evaluation [From baseline to end of treatment or up to 12 weeks, whichever comes first.]
Effectiveness parameters- clinical response will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.