Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02622724

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

Respiratory Distress Syndrome, Adult Clinical Trial

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 Severe Acute Respiratory Distress Syndrome

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02622724
Study type Interventional
Source Faron Pharmaceuticals Ltd
Contact
Status Terminated
Phase Phase 3
Start date December 23, 2015
Completion date May 23, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03712215 - STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT N/A
Completed NCT04582201 - Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2 Phase 1/Phase 2
Recruiting NCT01990456 - Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study N/A
Completed NCT01167621 - Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation N/A
Terminated NCT00233207 - IC14 Antibodies to Treat Individuals With Acute Lung Injury Phase 2
Completed NCT00029328 - Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation Phase 1/Phase 2
Completed NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00000579 - Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Phase 3
Recruiting NCT03236272 - Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
Withdrawn NCT04508933 - Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
Completed NCT02273687 - Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department N/A
Recruiting NCT03424798 - Measuring Heart and Lung Function in Critical Care N/A
Recruiting NCT01992237 - Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients N/A
Completed NCT00719446 - Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials N/A
Completed NCT00236262 - Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome N/A
Completed NCT00157144 - Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005 N/A
Completed NCT00300248 - Long-Term Results in Mechanically Ventilated Individuals With Acute Lung Injury/Acute Respiratory Distress Syndrome N/A
Completed NCT00141726 - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant Phase 2
Recruiting NCT00465374 - A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients Phase 3
Completed NCT00094406 - Carbon Monoxide to Prevent Lung Inflammation Phase 1