Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on Patients After Open Surgery for a RAAA

NCT03119701 ↗

Phase 2 Terminated 40 enrolled Faron Pharmaceuticals Ltd

RandomizedParallel-groupQuadruple-blindPrevention

Summary

A study to assess effectiveness and safety of a drug 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

Timeline

Start: 2017-02-18
Primary completion: 2019-09-23
Completion: 2019-10-03

Outcome

Missed primary endpoint

Stopped: “IDMC recommendation. Unexpectedly high use of concomitant corticosteroid treatment.”

registry analysis (superiority test); FP-1201-lyo 10 µg vs FP-1201-lyo Placebo; p = 0.78; Odds Ratio (OR) 1.30 (95% CI 0.21 to 8.19); NCT03119701 ↗

paper The initial aim of the trial, if postoperative INF beta-1a treatment results on better RAAA survival, could not be demonstrated. PMID 35115574 ↗

Publications

Hakovirta H, Jalkanen J, Saimanen E, Kukkonen T, Romsi P, Suominen V, Vikatmaa L, Valtonen M, Karvonen MK, Venermo M; INFORAAA Study Group. Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm: a randomized, double-blind, placebo-controlled study. Sci Rep. 2022 Feb 3;12(1):1839. doi: 10.1038/s41598-022-05771-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Interferon beta-1a	Protein / enzyme biologic	10 ug	Intravenous