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Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II

NCT00789685 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-05-27

Study results available
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Summary

The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

Conditions

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Interferon Beta

Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered.

Sponsors & Collaborators

Principal Investigators

  • Geoff Bellingan, MD · University College London Hospital

  • Martin Kuper, MD · Whittington Hospital

  • Martin Stotz, MD · St Mary's Hospital, London

  • Richard Beale, MD · St Thomas' Hospital

  • Mathew Wise, MD · University Hospital of Wales

  • Alexander Binning, MD · Western Infirmary

  • Alan Davidson, MD · Victoria Infirmary

  • Timothy Walsh, MD · Edinburgh Royal Infirmary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT00789685 on ClinicalTrials.gov