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
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|Condition or disease||Intervention/treatment|
|Aspergillosis Mucormycosis||Drug: Isauvuconazole group|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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|
- Drug: Isauvuconazole group
Patients who are treated with Isavuconazole according to its protocol label.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
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.
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
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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