INFORAAA study
Research type
Research Study
Full title
A Phase II Double-blind, Randomised, Parallel Group 2:1 Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon beta-la) and Placebo in the Prevention of Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm.
IRAS ID
230722
Contact name
Matti Karvonen
Contact email
Sponsor organisation
Faron Pharmaceuticals Ltd.
Eudract number
2014-000899-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 16 days
Research summary
The study is sponsored by Faron Pharmaceuticals Ltd and evaluates the efficacy and safety of FP-1201-lyo (recombinant human interferon beta-1a) in the prevention of multi-organ failure on patients after open surgery for a ruptured abdominal aortic aneurysm.
The purpose of this study is to investigate whether FP-1201-lyo can be used safely in post-surgical intensive care and whether the study drug can help to reduce multi organ failure and mortality following surgery. Interferon beta-1a has been used in long-term treatment of MS but it has not been investigated in the prevention of complications of multi-organ failure yet.
Patients are randomly assigned to treatment with FP-1201-lyo or placebo in randomisation ratio of 2:1 (active:placebo) for treatment groups, stratified by sex and age. Study treatments will be given in addition to other standard medications. Patients will receive FP-1201-lyo or placebo intravenously as a bolus injection once every 24 hours. The maximum duration of treatment will be 6 days. Patients continue to be monitored daily from D6 during hospitalisation. Final follow-up at D90 is conducted by review of patient's medical records or by telephone contact to the patient.
Study assessments include, but are not limited to: vital signs, physical examination, laboratory testing, hemodynamic collapse before clamping, proximal aortic clamp, mRS and SOFA scoring.
It is anticipated a total of 152 patients will be randomised in approximately 15 centres in 4 countries in Europe.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/0513
Date of REC Opinion
15 Jun 2018
REC opinion
Further Information Favourable Opinion