NCT04744454

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

A 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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Aspergillosis
• Mucormycosis

Interventions

Type	Name	Description
DRUG	Isauvuconazole group	Patients who are treated with Isavuconazole according to its protocol label.

Timeline

• Start date: 2021-10-28
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2021-02-09
• Last updated: 2026-04-13

Locations

1 site across 1 country: South Korea