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

NCT05630976 | Completed Phase 4 Results

• 2 other identifiers: C3791001NCT05630976
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 14

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.

Conditions

Invasive Fungal Disease

Keywords

Isavuconazole; Invasive Aspergillus; Invasive mold

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention. AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).

  From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)

Secondary Outcomes (20)

• All-cause Mortality Rate Through Day 42

  After first dose of study intervention (Day 1) through Day 42

• All-cause Mortality Rate Through Day 84

  After first dose of study intervention (Day 1) through Day 84

• Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population

  Day 42, Day 84 and EOT (any day before or at Day 180)

• Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population

  Day 42, Day 84 and EOT (any day before or at Day 84)

• Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population

  Day 42, Day 84 and EOT (any day before or at Day 180)

Study Arms (1)

Isavuconazole

EXPERIMENTAL

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

Drug: Isavuconazole

Interventions

Isavuconazole DRUG

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

Also known as: Cresemba®

Isavuconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi
• body weight \>40 kg at screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

The First Affiliated Hospital of USTC, Anhui Province Hospital

Hefei, Anhui, 230001, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Jieyang People's Hospital

Jieyang, Guangdong, 522095, China

Location

Henan provincial people's hospital

Zhengzhou, Henan, 450003, China

Location

Liaocheng people's Hospital

Liaocheng, Shandong, 252000, China

Location

Zibo Central Hospital

Zibo, Shandong, 255036, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Institute of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, 233000, China

Location

Jiading Central Hospital

Shanghai, 201800, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

isavuconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

"All-Cause Mortality" data reported in safety (AE) section is the number of confirmed (actual) deaths occurring up to the end of the study. In "All-Cause Mortality" related outcome measures, actual deaths plus unknown (not actual deaths but the numbers used in calculating results as planned) were also included for estimation at specified time points. Because of the same reason in outcome measure 3, total number of deaths (known + unknown) exceeds the ones reported in safety section.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 30, 2022
• Study Start: February 7, 2023
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: May 27, 2026
• Results First Posted: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (14)