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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00742482
• Other study ID #: HL 0101 INT
• Status: Terminated
• Phase: Phase 3
• First received: August 26, 2008
• Last updated: February 16, 2009
• Start date: January 2003
• Est. completion date: June 2005

Study information

• Verified date: February 2009
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Dutch Health Care InspectorateNorway: Norwegian Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 418
• Est. completion date: June 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• HL 10
Freeze dried HL 10

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin	Wien
Belgium	Erasme University Hospital	Brussels
Canada	Mount Sinai Hospital, Critical Care Unit	Toronto	Ontario
Denmark	Odense University Hospital	Odense C
Finland	Kuopio University Hospital, Intensive Care Unit	Kuopio
France	Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation	Paris
Germany	Klinik für Anästhesiologie der RWTH Aachen	Aachen
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Department of Intensive Care Medicine	Utrecht
Norway	Ullevål University Hospital, INtensive Care Department	Oslo
Spain	Consorci Hospitalari Parc Taulí	Sabadell (Barcelona)
Sweden	University Hospital of Lund, Department of Intensive Care	Lund
United Kingdom	St Thomas Hospital, Adult Intensive Care	London

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Netherlands,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 days mortality		28 days	No
Secondary	Days alive and off ventilator		Day 29	No
Secondary	Days on ventilation		Day 1 to Day 29	No
Secondary	Days alive and out of ICU		Day 29	No
Secondary	Changes in Pao2/FiO2 ratios and other relevant lung parameters, changes in SOFA score		From Day 1 to Day 4, Day 1 to Day 8, Day 4 to Day 8	No
Secondary	Dead/alive at discharge of ICU		Followed until Day 180	No
Secondary	Dear/alive at discharge from hospital		Followed until Day 180	No
Secondary	180 days mortality		180 days	No