NCT02622724

Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)

A Phase III Double-blind, Randomised, Parallel-Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human IFN Beta-1a) and Placebo in the Treatment of Patients With Moderate or Severe Acute Respiratory Distress Syndrome

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Faron Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.

Detailed description

This is a Phase III clinical study to investigate the efficacy and safety of FP-1201-lyo (recombinant human interferon \[IFN\] beta-1a) compared to placebo in patients diagnosed with moderate or severe acute respiratory distress syndrome (ARDS). Primary objective is to demonstrate the efficacy of FP-1201-lyo in improving the clinical course and outcome based on survival and need for mechanical ventilation. Currently there are no approved drugs for treating moderate or severe ARDS patients. FP-1201-lyo is a lyophilised powder form of recombinant human IFN beta-1a reconstituted in water for injection and is administered intravenously. Recombinant human IFN beta-1a is an approved treatment for patients for other indication and its safety profile in such patients is well characterised.

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
DRUG	Interferon beta-1a	Investigational drug
DRUG	Placebo	Placebo for investigational drug

Timeline

• Start date: 2015-12-23
• Primary completion: 2018-05-17
• Completion: 2018-05-23
• First posted: 2015-12-04
• Last updated: 2020-03-30
• Results posted: 2020-03-30

Locations

71 sites across 8 countries: Belgium, Czechia, Finland, France, Germany, Italy, Spain, United Kingdom