Efficacy and Safety of 3 Doses of HL10 Given at Fixed Time Intervals Compared to Standard Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742482
Recruitment Status : Terminated (A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.)
First Posted : August 27, 2008
Last Update Posted : February 17, 2009
Information provided by:
LEO Pharma

Brief 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

Condition or disease Intervention/treatment Phase
Acute Lung Injury Acute Respiratory Distress Syndrome Drug: HL 10 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : June 2005

Intervention Details:
  • Drug: HL 10
    Freeze dried HL 10

Primary Outcome Measures :
  1. 28 days mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Days alive and off ventilator [ Time Frame: Day 29 ]
  2. Days on ventilation [ Time Frame: Day 1 to Day 29 ]
  3. Days alive and out of ICU [ Time Frame: Day 29 ]
  4. 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 ]
  5. Dead/alive at discharge of ICU [ Time Frame: Followed until Day 180 ]
  6. Dear/alive at discharge from hospital [ Time Frame: Followed until Day 180 ]
  7. 180 days mortality [ Time Frame: 180 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742482

Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin
Wien, Austria, 1090
Erasme University Hospital
Brussels, Belgium, 1070
Canada, Ontario
Mount Sinai Hospital, Critical Care Unit
Toronto, Ontario, Canada, M5G 1X5
Odense University Hospital
Odense C, Denmark, 5000
Kuopio University Hospital, Intensive Care Unit
Kuopio, Finland, 70211
Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation
Paris, France, 75651
Klinik für Anästhesiologie der RWTH Aachen
Aachen, Germany, 52074
Academisch Medisch Centrum
Amsterdam, Netherlands, 1005
Department of Intensive Care Medicine
Utrecht, Netherlands, 3584
Ullevål University Hospital, INtensive Care Department
Oslo, Norway, 0407
Consorci Hospitalari Parc Taulí
Sabadell (Barcelona), Spain, 08208
University Hospital of Lund, Department of Intensive Care
Lund, Sweden, 221 85
United Kingdom
St Thomas Hospital, Adult Intensive Care
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
LEO Pharma
Principal Investigator: Jozef Kesecioglu, MD, PhD Anaesthesist-Intensivist, Department of Intensive Care Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Edmée Steenken/Project Co-ordinator, LEO Pharma A/S Identifier: NCT00742482     History of Changes
Other Study ID Numbers: HL 0101 INT
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries