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

NCT02622724 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2020-03-30

Study results available
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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.

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

DRUG

Interferon beta-1a

Investigational drug

DRUG

Placebo

Placebo for investigational drug

Sponsors & Collaborators

Principal Investigators

  • Geoffrey Bellingan, MD · University College London Hospitals, NHS, London, UK

  • V Marco Ranieri, Prof. MD · Universita La Sapeinza Policlinico Umberto I, Rome, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-23
Primary Completion
2018-05-17
Completion
2018-05-23

Countries

  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622724 on ClinicalTrials.gov