FibrosisPhase 2NCT00455767
Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients
A Phase 2 study testing EPI-hNE4 in people with Fibrosis and Lung Disease, run by Debiopharm International SA at 14 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosis, Lung Disease, Respiratory Disorders
- What is being tested?
- EPI-hNE4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Jul 2006to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from persistent ARDS as defined by the American and European Consensus Conference on ARDS, 1994
Who cannot join
- ARDS secondary to traumatism
- Pulmonary emphysema on pulmonary fibrosis
- Lung pneumocystosis
- Bronchopleural fistula
- Systemic corticosteroid treatment for more than 2 weeks before inclusion
- Severe organ disease excepted renal
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
France11 sites
Alain Mercat
Angers, 49933
Yves Castaing
Bordeaux, 33076
Laurent Brochard
Créteil, 94010
Jean-François Timsit
Grenoble, 38043
Claude Guerin
Lyon, 69004
Samir Jaber
Montpellier, 34295
Jean-Jacques Rouby
Paris, 75651
Jean-Daniel Chiche
Paris, 75679
Jean-Yves Fagon
Paris, 75908
Jean-Christophe Richard
Rouen, 76031
Jean-Michel Arnal
Toulon, 83100
About this 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
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.
Read the detailed description
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.
- Conditions
- Fibrosis, Lung Disease, Respiratory Disorders, Respiratory Distress Syndrome, Adult, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis
- Being tested
- EPI-hNE4, Placebo
- Keywords
- persistent ARDS, alveolar inflammation, early pulmonary fibrosis, mechanichal ventilation, P/V curve, Static compliance, elastase activity, inhibitor of Human Neutrophil Elastase
- Medical subject headings
- Fibrosis, Lung Diseases, Respiration Disorders, Respiratory Distress Syndrome, Pulmonary Fibrosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-hNE4Drug
I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Depelestat Receives: Drug: EPI-hNE4 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static compliance relative change from pre-treatment to last on treatment
Secondary outcomes (1)
PCPIII and cytokines concentration, as well as neutrophil influx relative change in BAL fluid from pre-treatment to post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startJul 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- François Saudubray, MD, Study director, Debiopharm SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455767
- Sponsor's protocol ID
- DEB-EPIV-201
- Other IDs
- 2006-000756-41 (EUDRACT NR)
- Status last verified
- Jun 2008
- First submitted
- 14 Mar 2007
- Last updated
- 24 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Honore S, Attalah HL, Azoulay E, Soussy CJ, Saudubray F, Harf A, Brochard L, Delclaux C. Beneficial effect of an inhibitor of leukocyte elastase (EPI-hNE-4) in presence of repeated lung injuries. Shock. 2004 Aug;22(2):131-6. doi: 10.1097/01.shk.0000126861.77543.d0.
PubMed 15257085
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIA Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00455767
- Acronym / sponsor ID
- DEB-EPIV-201
- Conditions
- Fibrosis, Lung Disease, Respiratory Disorders, Respiratory Distress Syndrome, Adult, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis
- Keywords
- persistent ARDS, alveolar inflammation, early pulmonary fibrosis, mechanichal ventilation, P/V curve, Static compliance, elastase activity, inhibitor of Human Neutrophil Elastase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EPI-hNE4Depelestat |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from persistent ARDS as defined by the American and European Consensus Conference on ARDS, 1994
Key exclusion criteria (6 listed)
- ARDS secondary to traumatism
- Pulmonary emphysema on pulmonary fibrosis
- Lung pneumocystosis
- Bronchopleural fistula
- Systemic corticosteroid treatment for more than 2 weeks before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPI-hNE4I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Static compliance relative change from pre-treatment to last on treatment
1 secondary outcome
PCPIII and cytokines concentration, as well as neutrophil influx relative change in BAL fluid from pre-treatment to post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2008.
- Background: PubMed 15257085Honore S, Attalah HL, Azoulay E, Soussy CJ, Saudubray F, Harf A, Brochard L, Delclaux C. Beneficial effect of an inhibitor of leukocyte elastase (EPI-hNE-4) in presence of repeated lung injuries. Shock. 2004 Aug;22(2):131-6. doi: 10.1097/01.shk.0000126861.77543.d0.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Saudubray, MD study director
Debiopharm SA
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EPI-hNE4 in people with Fibrosis and Lung Disease, run by Debiopharm International SA at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Italy, Spain, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static compliance relative change from pre-treatment to last on treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00455767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2008.