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

This study has been terminated.
(A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.)
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00742482
First received: August 26, 2008
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Acute Lung Injury
Acute Respiratory Distress Syndrome
Drug: HL 10
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • 28 days mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days alive and off ventilator [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Days on ventilation [ Time Frame: Day 1 to Day 29 ] [ Designated as safety issue: No ]
  • Days alive and out of ICU [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Dead/alive at discharge of ICU [ Time Frame: Followed until Day 180 ] [ Designated as safety issue: No ]
  • Dear/alive at discharge from hospital [ Time Frame: Followed until Day 180 ] [ Designated as safety issue: No ]
  • 180 days mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Enrollment: 418
Study Start Date: January 2003
Study Completion Date: June 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: HL 10
    Freeze dried HL 10
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742482

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

No publications provided by LEO Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edmée Steenken/Project Co-ordinator, LEO Pharma A/S
ClinicalTrials.gov Identifier: NCT00742482     History of Changes
Other Study ID Numbers: HL 0101 INT
Study First Received: August 26, 2008
Last Updated: February 16, 2009
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Dutch Health Care Inspectorate
Norway: Norwegian Medicines Agency
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 28, 2014