Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/1/2018 |
| Start Date: | June 6, 2018 |
| End Date: | February 2021 |
| Contact: | Paul Newell |
| Email: | PNewell@f2g.com |
| Phone: | 44 07766 130849 |
Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options
A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in
patients lacking suitable alternative treatment options.
patients lacking suitable alternative treatment options.
This is the first study in patients of F901318. Patients with a limited treatment options
will be enrolled and treated with F901318 (olorofim) for up to 12 weeks.
will be enrolled and treated with F901318 (olorofim) for up to 12 weeks.
Inclusion Criteria:
- Male and female aged 18 or older whom have given informed consent
- Ability to comply with the protocol
- Females must be non lactating and not at risk of pregnancy
- Patients with invasive fungal disease
- Patients who have limited alternative treatment options
Exclusion Criteria:
- Women who are pregnant or breast feeding
- Known history of allergy hypersensitivity to any study drug components
- Patients with chronic aspergillosis
- HIV patients who are not receiving antiretroviral therapy
- Previously enrolled patients or patients enrolled in any clinical trial within the
last 30 days
- Patients with a medical condition that may jeopardize adherence to the protocol or may
cause unacceptable additional risk to the patient
- Patients with predicted short survival time
- Prohibited concomitant medications
We found this trial at
2
sites
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Francisco Marty
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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