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

February 21, 2025 updated by: LEO Pharma

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: HL 10

Study Type

Interventional

Enrollment (Actual)

418

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28 days mortality Time Frame: 28 days	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
180 days mortality Time Frame: 180 days	180 days
Days alive and off ventilator Time Frame: Day 29	Day 29
Days on ventilation Time Frame: Day 1 to Day 29	Day 1 to Day 29
Days alive and out of ICU Time Frame: Day 29	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	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	Followed until Day 180
Dear/alive at discharge from hospital Time Frame: Followed until Day 180	Followed until Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

Principal Investigator: Jozef Kesecioglu, MD, PhD, Anaesthesist-Intensivist, Department of Intensive Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria