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Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05630976
Collaborator
(none)
56
Enrollment
1
Arm
33.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing setting.

This is a single arm, prospective, multi-center study. This study is seeking Chinese patients with proven, probable or possible Invasive Fungal Disease (IFD) caused by Aspergillus species or other filamentous fungi. All the participants will receive isavuconazole treatment. The longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with IM).

The primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Sep 28, 2025
Anticipated Study Completion Date :
Nov 2, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Isavuconazole

This is a single arm study, all enrolled participants will receive the study medication.

Drug: Isavuconazole
This is a single arm study, all enrolled participants will receive the study intervention.
Other Names:
  • Cresemba®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rates of Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Prothrombin Time (PT) [From Baseline up to 180 Days]

    Secondary Outcome Measures

    1. Percentage of all-cause mortality following primary treatment with isavuconazole. [Day 42]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi

    • body weight >40 kg at screening

    Exclusion Criteria:

    • either chronic aspergillosis, aspergilloma, or ABPA

    • Advanced HIV infection with CD4 count < 200 or acquired immunodeficiency syndrome-defining condition

    • people who are unlikely to survive 5 days or participants on mechanical ventilation

    • severe hepatic impairment (Child-Pugh Class C)

    • familial short QT syndrome

    • Concomitant use of efavirenz, ritonavir, etravirine, rifampicin/rifampin, rifabutin, nafcillin, ketoconazole, or St. John's Wort in the 5 days prior to first administration of study intervention

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05630976
    Other Study ID Numbers:
    • C3791001
    First Posted:
    Nov 30, 2022
    Last Update Posted:
    Nov 30, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycoses
    Invasive Fungal Infections
    Isavuconazole

    Study Results

    No Results Posted as of Nov 30, 2022