OASIS F901318/0041
Research type
Research Study
Full title
A Phase 3 , adjudicator-blinded, randomised study t evaluate the efficacy and safety of treatment with AmBisome followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aperigillus species.
IRAS ID
302060
Contact name
Varun Mehra
Contact email
Sponsor organisation
F2G Ltd
Eudract number
2021-000386-32
Duration of Study in the UK
2 years, 11 months, 3 days
Research summary
This study will evaluate the safety and efficacy of an investigational medication in treating Invasive Aspergillosis (IA). Aspergillus species are a type of fungus found in organic matter or the environment. Apergillus infections may lead to a number of diseases in humans including direct invasion of tissue. IA is a very progressive and often fatal infection commonly affecting patients who are immunocompromised. From some patients who do not respond to or cannot tolerate current therapies for IA treatment options are limited. Some treatments are only available intravenously and are associated with high risk to renal function, while others have limited efficacy. This study will compare how well the investigational medicine is tolerated, how effective and how safe it is compared to an already approved treatment for this indication. The study drug is an antifungal which works by stopping a type of protein, an enzyme, that contributes to the development of the fungus. This study will be open to patients who have been diagnosed with IA. Participants in this study will be randomised to either the investigational medicine or the approved treatment and will take part for up to 18 weeks. The study has 3 phases: the screening phase (up to 2 days before treatment), a treatment phase (up to 12 weeks) and a Follow up phase (up to 4 weeks post last dose). In case the infection is clinically resolved sooner, participants will have fewer study related visits.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0298
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion