INTEREST study
Research type
Research Study
Full title
A Phase III Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon Beta-1a) and Placebo in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome
IRAS ID
182147
Contact name
Ilse Piippo
Contact email
Sponsor organisation
Faron Pharmaceuticals Ltd
Eudract number
2014-005260-15
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study is Sponsored by Faron Pharmaceuticals Ltd. and explores a potential new treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS results in the leaking of fluid from lungs, inflammation and respiratory failure. This is a serious condition which can be life-threatening.
There are currently no approved pharmacological treatments for ARDS and standard of care is currently management of the condition with supportive care.
The treatment proposed in this research study is a pharmacological compound called FP-1201-lyo (recombinant human interferon IFN beta-1a) which has already been investigated. Results from previous studies suggest this new treatment would have beneficial effects in patients with ARDS in reducing leakage from the lungs.
The purpose of this study is to evaluate the safety and effectiveness of FP-1201-lyo in improving survival and reducing the need for mechanical ventilation.
Patients will be randomly assigned to one of two treatments - FP-1201-lyo or placebo. Treatments will be given in addition to receiving their standard of care. Patients included in the study will be given study medication once daily for 6 days by intravenous injection or through the in situ central/ peripheral line. The patients will continue to be monitored daily from D7 to Day 28 or until they are discharged from the Intensive Care Unit (ICU). Follow up visits will then take place at days 90, 180 and 360 days.
Study assessments conducted will include, but are not limited to: vital signs, physical examination,blood sampling and self-completed questionnaires. Patients will also be provided the opportunity to join the pharmacogenetic portion of the study which involve an additional blood sample draw.
It is anticipated a total of 300 patients will be randomised in approximately 60 centres in 9 countries across Europe.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/2098
Date of REC Opinion
23 Dec 2015
REC opinion
Favourable Opinion