search
Back to results

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

Primary Purpose

Invasive Fungal Disease

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Isavuconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Fungal Disease focused on measuring Isavuconazole, Invasive Aspergillus, Invasive mold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Anhui Provincial Hospital
  • The First Affiliated Hospital of USTC, Anhui Province HospitalRecruiting
  • Anhui Provincial Hospital
  • Peking University Third Hospital
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Guangzhou First People's HospitalRecruiting
  • ZhuJiang Hospital of Southern Medical UniversityRecruiting
  • Jieyang People's HospitalRecruiting
  • Henan provincial people's hospital
  • The Third Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Suzhou University
  • The First Affiliated Hospital of Suzhou University
  • Qilu Hospital of Shandong UniversityRecruiting
  • Liaocheng people's Hospital
  • Zibo Central HospitalRecruiting
  • Zibo Central Hospital
  • Shanghai Ninth People's Hospital
  • Huashan Hospital, Fudan UniversityRecruiting
  • Institute of Hematology, Chinese Academy of Medical SciencesRecruiting
  • The First Affiliated Hospital Zhejiang UniversityRecruiting
  • Peking University People's Hospital
  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Isavuconazole

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC)

Secondary Outcome Measures

Percentage of all-cause mortality following primary treatment with isavuconazole.
Crude rate of overall response at EOT
Responses based on the investigators' assessment at EOT
Crude rate of success of the clinical response at EOT
Responses based on the investigators' assessment at EOT
Crude rate of success of the mycological response at EOT
Responses based on the investigators' assessment at EOT
Crude rate success of the radiological responses at EOT
Responses based on the investigators' assessment at EOT
Number of Participants with TEAEs related to study intervention
Number of Participants with TE Serious Adverse Event (SAEs) related to study intervention
Number of Participants with TEAE leading to discontinuation of study intervention
Number of Participants with TEAE leading to deaths
Number of all deaths
Number of Participants with Clinical Laboratory Abnormalities
Number of Participants with Vital Signs Abnormalities
Number of Participants with Abnormal Electrocardiogram (ECG)
Number of Participants with Abnormal Eye Examination.
Isavuconazole plasma concentration

Full Information

First Posted
November 18, 2022
Last Updated
September 8, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT05630976
Brief Title
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
May 23, 2025 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Disease
Keywords
Isavuconazole, Invasive Aspergillus, Invasive mold

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isavuconazole
Arm Type
Experimental
Arm Description
This is a single arm study, all enrolled participants will receive the study medication.
Intervention Type
Drug
Intervention Name(s)
Isavuconazole
Other Intervention Name(s)
Cresemba®
Intervention Description
This is a single arm study, all enrolled participants will receive the study intervention.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC)
Time Frame
From Baseline to End of Study (EOS) and Prothrombin Time (PT)
Secondary Outcome Measure Information:
Title
Percentage of all-cause mortality following primary treatment with isavuconazole.
Time Frame
Day 42 and Day 84
Title
Crude rate of overall response at EOT
Description
Responses based on the investigators' assessment at EOT
Time Frame
Day 42, and 84
Title
Crude rate of success of the clinical response at EOT
Description
Responses based on the investigators' assessment at EOT
Time Frame
Day 42, and 84
Title
Crude rate of success of the mycological response at EOT
Description
Responses based on the investigators' assessment at EOT
Time Frame
Day 42, and 84
Title
Crude rate success of the radiological responses at EOT
Description
Responses based on the investigators' assessment at EOT
Time Frame
Day 42, and 84
Title
Number of Participants with TEAEs related to study intervention
Time Frame
Day 42, and 84
Title
Number of Participants with TE Serious Adverse Event (SAEs) related to study intervention
Time Frame
Day 42, and 84
Title
Number of Participants with TEAE leading to discontinuation of study intervention
Time Frame
Day 42, and 84
Title
Number of Participants with TEAE leading to deaths
Time Frame
Day 42, and 84
Title
Number of all deaths
Time Frame
Day 42, and 84
Title
Number of Participants with Clinical Laboratory Abnormalities
Time Frame
Day 42, and 84
Title
Number of Participants with Vital Signs Abnormalities
Time Frame
Day 42, and 84
Title
Number of Participants with Abnormal Electrocardiogram (ECG)
Time Frame
Day 42, and 84
Title
Number of Participants with Abnormal Eye Examination.
Time Frame
Day 42, and 84
Title
Isavuconazole plasma concentration
Time Frame
Day 3, 7, 14, and EOT visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of USTC, Anhui Province Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230071
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
ZhuJiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Name
Jieyang People's Hospital
City
Jieyang
State/Province
Guangdong
ZIP/Postal Code
522095
Country
China
Individual Site Status
Recruiting
Facility Name
Henan provincial people's hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215031
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Liaocheng people's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Zibo Central Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255036
Country
China
Individual Site Status
Recruiting
Facility Name
Zibo Central Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255036
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3791001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs