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Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients

NCT00455767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2008-06-24

No results posted yet for this study

Summary

The study is aimed to assess safety of Depelestat treatment, as well as efficacy on prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients suffering from persistent Acute Respiratory Distress Syndrome.

Conditions

Interventions

DRUG

EPI-hNE4

I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Debiopharm International SA

    lead INDUSTRY

Principal Investigators

  • François Saudubray, MD · Debiopharm SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • France
  • Italy
  • Spain
  • Tunisia

Study Locations

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Entities

Drugs
Diseases

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 NCT00455767 on ClinicalTrials.gov