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Sponsored by: |
Debiopharm S.A. |
Information provided by: | Debiopharm S.A. |
ClinicalTrials.gov Identifier: | NCT00455767 |
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.
Condition | Intervention | Phase |
Fibrosis Lung Disease Respiratory Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome Pulmonary Fibrosis Inflammation |
Drug: EPI-hNE4 Drug: Placebo |
Phase II |
MedlinePlus related topics: | Pulmonary Fibrosis |
Drug Information available for: | Depelestat |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IIA Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome |
Enrollment: | 84 |
Study Start Date: | July 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Depelestat
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Drug: EPI-hNE4
I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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This is a multicenter, randomised, double-blind, parallel groups, placebo-controlled, 1 week treatment of Depelestat, in patients suffering from persistent ARDS.
Patients admitted in the intensive care unit presenting ARDS criteria persistent for 12 hours to 24 hours, will be randomly assigned to the treatment by Depelestat or placebo, after a pre-treatment period as short as possible with a maximum of 48 hours since ARDS criteria are met. During the pre-treatment period, the informed consent will be obtained from the legally authorized relative of the patient, and pre-treatment biological and functional examinations will be performed, particularly blood samples and BAL for biological parameters measurement, and ventilatory mechanics, for assessment of static compliance of the respiratory system.
After the pre-treatment period, the patient will receive treatment by Depelestat or placebo during 7 days, or until extubation of the patient if this occurs before 7 days of treatment. During this treatment period, the patient will be submitted to a daily measurement of static compliance of the respiratory system, as long as the patient adaptation to 24 hours after mechanical ventilation allows the procedure, and at 96 initiation of treatment, to a blood sampling and a bronchoalveolar lavage for several biological parameters assessment.
On the first and last day of administration, blood will be also collected for pharmacokinetic evaluation.
During the post-treatment period, the patient will be submitted, at 48 h ± 24 h after the end of treatment, to a blood sampling and a BAL (this BAL is not performed when contraindication criteria are present, if the patient is already extubated, and in case of planed extubation during the subsequent 24 hours) for several biological parameters assessment, and a daily measurement of static compliance as long as the patient adaptation to mechanical ventilation allows the procedure. Patients already extubated will not be submitted to BAL nor to static compliance measurements.
After the end of the treatment, patients will be followed daily for 28 days after the diagnostic of ARDS, or until death whichever occurred first.
The duration of the study for each survivor patient will be 28 days. Survivors to day 28 will be contacted monthly to assess survival and fill in a QOL questionnaire on days 60 and 90.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
Yves Castaing | |||||
Bordeaux, France, 33076 | |||||
Jean-Daniel Chiche | |||||
Paris Cedex, France, 75679 | |||||
Jean-Yves Fagon | |||||
Paris Cedex 15, France, 75908 | |||||
Jean-Christophe Richard | |||||
Rouen Cedex, France, 76031 | |||||
Samir Jaber | |||||
Montpellier Cedex 05, France, 34295 | |||||
Alain Mercat | |||||
Angers, France, 49933 | |||||
Claude Guerin | |||||
Lyon, France, 69004 | |||||
Jean-François Timsit | |||||
Grenoble Cedex 09, France, 38043 | |||||
Jean-Jacques Rouby | |||||
Paris, France, 75651 | |||||
Jean-Michel Arnal | |||||
Toulon, France, 83100 | |||||
Laurent Brochard | |||||
Créteil Cedex, France, 94010 | |||||
Italy | |||||
Massimo Antonelli | |||||
Roma, Italy, 00168 | |||||
Spain | |||||
Jordi Mancebo D. | |||||
Barcelona, Spain, 08025 | |||||
Tunisia | |||||
Fekri Abroug | |||||
Monastir, Tunisia |
Debiopharm S.A. |
Study Director: | François Saudubray, MD | Debiopharm SA |
Related Info 
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Responsible Party: | Debiopharm S.A. ( François Saudubray, M.D. ) |
Study ID Numbers: | DEB-EPIV-201, 2006-000756-41 (EUDRACT NR) |
First Received: | March 14, 2007 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00455767 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Tunisia: Office of Pharmacies and Medicines; Italy: Ethics Committee; Spain: Spanish Agency of Medicines |
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