Acute Lung InjuryPhase 3NCT00742482
Efficacy and Safety of 3 Doses of HL10 Given at Fixed Time Intervals Compared to Standard Therapy
A Phase 3 study testing HL 10 in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by LEO Pharma at 13 sites in 12 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome
- What is being tested?
- HL 10
- How many people
- 418 participants
- Where
- 13 sitesin 12 countries
- Study dates
- Jan 2003to Jun 2005
- Phase
- Phase 3
- 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 intubated and on mechanical ventilation
- Patients with Acute Lung Injury defined as (a, b, c and d are all applicable): a: PaO2/FiO2 < or equal to 300 mmHg (40.0 kPa) (regardless of PEEP level), b: Acute onset, c: Pulmonary artery wedge pressure < or equal to 18 mmHg when measured or no clinical evidence of left atrial hypertension, d: Bilateral infiltrates seen on frontal chest radiograph
- Less than 60 hours from onset of the present period of mechanical ventilation to 1st instillation
- Expected to continue on mechanical ventilation for more than 24 hours
- 18 years of age or older
- Following receipt of verbal and written information about the trial, the patient or legally acceptable representative must provide signed and dated informed consent before any trial related activity is carried out
Who cannot join
- Current diagnosis of acute bronchial asthma attack
- History of or clinical suspicion of lung fibrosis
- Current diagnosis of suspected pulmonary thrombo-embolism
- Patients on daily medication for chronic obstructive pulmonary disease at time of admission to ICU
- Patients who have received mechanical ventilation for more than 48 hours continuously within 1 month prior to the present period of mechanical ventilation
- Patients with pneumonectomy or lobectomy
Show all 20Show fewer
- Patients with untreated pneumothorax at time of instillation
- Patients having tracheostomy at time of instillation
- Patients who have had surgical procedures under general anaesthesia performed within 6 hours prior to inclusion blood gas sample
- Patients having mean arterial blood pressure < 50 mmHg in spite of adequate fluid administration and/or vasoactive drugs at time of instillation
- Patients having PaO2 < 75 mmHg with a FiO2 = 1.0 not responding to adjustment of PEEP at time of instillation
- Glasgow Coma Score < or equal to 10 before sedation or major findings on CT/MR scan of the head such as: brain oedema, acute space occupying lesion, other acute lesions with bleeding or mass effect (patients with minor lesion which do not require further diagnostics or monitoring can be included)
- Patients with life expectancy less than 3 months due to primary disease assessed by the attending physician (e.g., end-stage cancer, AIDS or generally poor health)
- Known or suspected hypersensitivity to constituents(s) of the investigational product
- Patients who have received treatment with any investigational drug within the previous 4 weeks
- Current participation in any other interventional clinical trial until day 29 of the trial
- Patients previously randomised in this trial
- Patients known or suspected of not being able to comply with a study protocol (e.g., due to alcoholism, drug dependency or psychotic state)
- Females of childbearing potential who have a positive pregnancy test or who are breast feeding
- Patients suffering from highly infectious diseases where trial related procedures could pose a safety risk for the staff (e.g., SARS)
Trial locations and contacts
13 sites in 12 countries.
13 sites in 12 countries
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam, 1005
Department of Intensive Care Medicine
Utrecht, 3584
Austria1 site
Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin
Vienna, 1090
Canada1 site
Mount Sinai Hospital, Critical Care Unit
Toronto, Ontario, M5G 1X5
France1 site
Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation
Paris, 75651
Sweden1 site
University Hospital of Lund, Department of Intensive Care
Lund, 221 85
United Kingdom1 site
St Thomas Hospital, Adult Intensive Care
London, SE1 7EH
About this study
Official title: A Phase III Study With Freeze Dried HL10, Three Dosages of 200 mg/kg Ideal Body Weight Versus Standard Therapy in ALI/ARDS Patients
The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy
- Being tested
- HL 10
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL 10Drug
Freeze dried HL 10
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days mortality
Measured: 28 days
Secondary outcomes (7)
Days alive and off ventilator
Measured: Day 29
Days on ventilation
Measured: Day 1 to Day 29
Days alive and out of ICU
Measured: Day 29
Changes in Pao2/FiO2 ratios and other relevant lung parameters, changes in SOFA score
Measured: From Day 1 to Day 4, Day 1 to Day 8, Day 4 to Day 8
Dead/alive at discharge of ICU
Measured: Followed until Day 180
Dear/alive at discharge from hospital
Measured: Followed until Day 180
180 days mortality
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startJan 2003
- Primary completionJan 2005
- Study completionJun 2005
Why it stopped: A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jozef Kesecioglu, MD, PhD, Principal investigator, Anaesthesist-Intensivist, Department of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742482
- Sponsor's protocol ID
- HL 0101 INT
- Status last verified
- Feb 2009
- First submitted
- 26 Aug 2008
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lu Q, Zhang M, Girardi C, Bouhemad B, Kesecioglu J, Rouby JJ. Computed tomography assessment of exogenous surfactant-induced lung reaeration in patients with acute lung injury. Crit Care. 2010;14(4):R135. doi: 10.1186/cc9186. Epub 2010 Jul 15.
PubMed 20633284Kesecioglu J, Beale R, Stewart TE, Findlay GP, Rouby JJ, Holzapfel L, Bruins P, Steenken EJ, Jeppesen OK, Lachmann B. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2009 Nov 15;180(10):989-94. doi: 10.1164/rccm.200812-1955OC. Epub 2009 Aug 27.
PubMed 19713451
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study With Freeze Dried HL10, Three Dosages of 200 mg/kg Ideal Body Weight Versus Standard Therapy in ALI/ARDS Patients
- ClinicalTrials.gov ID
- NCT00742482
- Acronym / sponsor ID
- HL 0101 INT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.
- Enrolment
- 418 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 27 Aug 2008 (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 purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients intubated and on mechanical ventilation
- Patients with Acute Lung Injury defined as (a, b, c and d are all applicable): a: PaO2/FiO2 < or equal to 300 mmHg (40.0 kPa) (regardless of PEEP level), b: Acute onset, c: Pulmonary artery wedge pressure < or equal to 18 mmHg when measured or no clinical evidence of left atrial hypertension, d: Bilateral infiltrates seen on frontal chest radiograph
- Less than 60 hours from onset of the present period of mechanical ventilation to 1st instillation
- Expected to continue on mechanical ventilation for more than 24 hours
- 18 years of age or older
Key exclusion criteria (20 listed)
- Current diagnosis of acute bronchial asthma attack
- History of or clinical suspicion of lung fibrosis
- Current diagnosis of suspected pulmonary thrombo-embolism
- Patients on daily medication for chronic obstructive pulmonary disease at time of admission to ICU
- Patients who have received mechanical ventilation for more than 48 hours continuously within 1 month prior to the present period of mechanical ventilation
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 |
|---|---|---|
| HL 10Freeze dried HL 10 | Drug | – |
Primary outcome
28 days mortality
Time frame: 28 days
7 secondary outcomes
Days alive and off ventilator
Time frame: Day 29
Days on ventilation
Time frame: Day 1 to Day 29
Days alive and out of ICU
Time frame: Day 29
Changes in Pao2/FiO2 ratios and other relevant lung parameters, changes in SOFA score
Time frame: From Day 1 to Day 4, Day 1 to Day 8, Day 4 to Day 8
Dead/alive at discharge of ICU
Time frame: Followed until Day 180
Dear/alive at discharge from hospital
Time frame: Followed until Day 180
180 days mortality
Time frame: 180 days
Results and safety
The study was stopped early (reason given: A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 20633284Lu Q, Zhang M, Girardi C, Bouhemad B, Kesecioglu J, Rouby JJ. Computed tomography assessment of exogenous surfactant-induced lung reaeration in patients with acute lung injury. Crit Care. 2010;14(4):R135. doi: 10.1186/cc9186. Epub 2010 Jul 15.
- Derived from this study: PubMed 19713451Kesecioglu J, Beale R, Stewart TE, Findlay GP, Rouby JJ, Holzapfel L, Bruins P, Steenken EJ, Jeppesen OK, Lachmann B. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2009 Nov 15;180(10):989-94. doi: 10.1164/rccm.200812-1955OC. Epub 2009 Aug 27.
- Individual participant dataSharing planned: No
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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.
Jozef Kesecioglu, MD, PhD principal investigator
Anaesthesist-Intensivist, Department of Intensive Care Medicine
13 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HL 10 in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by LEO Pharma at 13 sites in 12 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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Austria, Belgium, Canada, Denmark and 7 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.). Results are not available in the source record.
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?
28 days mortality (time frame: 28 days). 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 NCT00742482, which also lists 2 linked publications.
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 Feb 2025.