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Efficacy and Safety of 3 Doses of HL10 Given at Fixed Time Intervals Compared to Standard Therapy | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

A Phase III Study With Freeze Dried HL10, Three Dosages of 200 mg/kg Ideal Body Weight Versus Standard Therapy in ALI/ARDS Patients

NCT00742482•LEO Pharma

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+10 more criteria

Locations (13)

Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin

Vienna, Austria

Erasme University Hospital

Brussels, Belgium

Mount Sinai Hospital, Critical Care Unit

Toronto, Ontario, Canada

Odense University Hospital

Odense C, Denmark

Kuopio University Hospital, Intensive Care Unit

Kuopio, Finland

Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation

Paris, France

Klinik für Anästhesiologie der RWTH Aachen

Aachen, Germany

Academisch Medisch Centrum

Amsterdam, Netherlands

Department of Intensive Care Medicine

Utrecht, Netherlands

Ullevål University Hospital, INtensive Care Department

Oslo, Norway

Key Dates

Start Date

January 1, 2003

Primary Completion Date

January 1, 2005

Completion Date

June 1, 2005

Last Updated

February 24, 2025

Enrollment

418

ACTUAL participants

Conditions

Acute Lung InjuryAcute Respiratory Distress Syndrome

Interventions

HL 10

DRUG

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

NCT07450846

Acute Respiratory Distress SyndromeRight Heart Failure

View study

RECRUITING

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

NCT07414056

Acute Respiratory Distress Syndrome (ARDS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Assessment of Airway Opening Pressure in Invasively Ventilated Children

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury