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NCT06433128 Clinical Trial

Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections

Invasive Fungal Infections Clinical Trial

Official title:
Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT06433128
Other study ID # EAP to Fosmanogepix
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date May 2024
Source Basilea Pharmaceutica
Contact WEP-Clinical Pharmaceutical Services Provider
Email fosmanogepixeap@wepclinical.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fosmanogepix solution for infusion
Fosmanogepix solution for infusion, 20 mg/mL for intravenous administration
• Fosmanogepix 400 mg tablets
Fosmanogepix 400 mg tablets for oral administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Basilea Pharmaceutica
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