Clinical Trial: Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Seve
Brief 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 Summary:
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.
Sponsor: Faron Pharmaceuticals Ltd
Current Primary Outcome:
- Efficacy Endpoint: Any cause death [ Time Frame: Day 28 ]Primary Efficacy Endpoint: Composite endpoint including any cause death at D28
- Efficacy Endpoint: Days free of mechanical ventilation [ Time Frame: Day 28 ]Primary Efficacy Endpoint: Composite endpoint including days free of mechanical ventilation (VFDsurv) within 28 days among survivors
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evaluation of Safety: Adverse events and all deaths [ Time Frame: Up to Day 28, after Day 28 and up to Day 360 ]Adverse events [AE] up to D28, AEs occurring after D28 if the investigator considers there is a causal relationship with the study drug and all deaths up to D360
- Efficacy Endpoint: All-cause mortality [ Time Frame: At Day 28, Day 90 and Day 180 ]
- Efficacy Endpoint: Mortality in ICU [ Time Frame: Up to Day 28 ]
- Efficacy Endpoint: Mortality in hospital [ Time Frame: Up to Day 28 ]
- Other secondary efficacy endpoints: Days free of organ failure [ Time Frame: Day 28 ]Sequential Organ Failure Assessment methodology
- Other secondary efficacy endpoints: Days free of renal support [ Time Frame: Day 28 ]
- Other secondary efficacy endpoints: Days free of vasoactive support [ Time Frame: Day 28 ]
- Other secondary efficacy endpoints: Days free of mechanical ventilation [ Time Frame: Day 28 ]
- Other secondary efficacy endpoints: Number of ICU-free days [ Time Frame: Day 28 ]
- Other secondary efficacy endpoints: Number of days in hospital [ Time Frame: Day 28 ]
- Efficacy Endpoint: Presence of neutralising antibodies to IFN beta-1a [ Time Frame: Baseline and Day 28 (or last day in intensive care unit [ICU] or at withdrawal, if earlier) ]
- Efficacy Endpoint: Evaluation of pharmacodynamic [PD] using Myxovirus resistance protein A [MxA] biomarker [ Time Frame: From baseline to Day 14 ]
- Long-term efficacy endpoints relating to Quality of Life [Qol] [ Time Frame: Day 180 ]EuroQol 5-Dimensions 3-Levels questionnaire [EQ-5D-3L]
- Long-term efficacy endpoints relating to respiratory functioning [ Time Frame: Day 180 ]Forced expiratory volume in 1 second [FEV1]
- Long-term efficacy endpoints relating to neurological functioning [ Time Frame: Day 180 ]6-minute walk test [6MWT]
- Evaluation of Safety: Physical examination [ Time Frame: From baseline to Day 28 ]
- Evaluation of Safety: Vital signs [ Time Frame: From baseline to Day 28 ]
- Evaluation of Safety: Laboratory results [ Time Frame: From baseline to Day 28 ]Biochemistry, haematology and urinalysis
Original Secondary Outcome: Same as current
Information By: Faron Pharmaceuticals Ltd
Dates:
Date Received: November 24, 2015
Date Started: November 2015
Date Completion: April 2018
Last Updated: August 2, 2016
Last Verified: August 2016