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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04744454
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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
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
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Study Type : Observational
Estimated 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 : October 28, 2021
Estimated Primary Completion Date : January 30, 2026
Estimated Study Completion Date : January 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Groups and Cohorts
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Intervention Details:
  • Drug: Isauvuconazole group
    Patients who are treated with Isavuconazole according to its protocol label.

Outcome Measures
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Primary Outcome Measures :
  1. Adverse event (AE) as safety evaluation [ Time Frame: 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 :
  1. Effectiveness evaluation [ Time Frame: From baseline to end of treatment or up to 12 weeks, whichever comes first. ]
    Effectiveness parameters- clinical response will be evaluated.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study is performed in accordance with routine clinical practice as per regulatory requirement. Therefore, inclusion and exclusion criteria relate to the labelled indication and contraindications. (Refer to the most updated version of the local product document [LPD]) All patients initiated on Isavuconazole and provided informed consent to the study will be enrolled continuously up to the planned number of enrolled patients. The assignment of the patient to Isavuconazole is decided by the investigator if he/she considers administering as per the current practice would provide clinical benefit with regards to safety and effectiveness.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744454


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Pfizer Korea Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04744454    
Other Study ID Numbers: C3791006
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Aspergillosis
Mucormycosis
Isavuconazole
Korean
Additional relevant MeSH terms:
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Aspergillosis
Mucormycosis
Zygomycosis
 Mycoses
Bacterial Infections and Mycoses
Infections