A trial examining the effects of alteplase in patients with severe respiratory failure.

Phase 1

• Conditions: acute lung injury, acute respiratory distress syndrom, severe pneumonia; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-024377-40-AT
• Lead Sponsor: Medizinische Universität Wien, UniKlinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-23
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects fulfilling the criteria for ALI/ARDS/severe pneumonia and need for a ventilator
Negative urine pregnancy test
acute stage ALI/ARDS/severe pneumonia
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Known or suspected allergy to trial product or related products
•History of heparin induced thrombocytopenia type II
•Treatment with an investigational drug within three weeks prior to this trial
•Pregnancy (pregnancy will be ruled out in women of childbearing age by urine test)
•Severe bleeding disorder (acute or within last 6 months)
•Known bleeding diathesis
•Patients on oral anticoagulant therapy at randomization
•Overt or recent severe or life-threatening bleeding
•Present or known or suspected intracranial bleeding
•Suspicion of subarachnoid hemorrhage or history of aneurismal subarachnoid hemorrhage
•History of intracranial neoplasm, aneurysm, intracranial or intraspinal surgery
•Recent (less than 10 days) traumatic CPR, obstetric delivery;
•Severe uncontrolled arterial hypertension
•Bacterial endocarditis, pericarditis
•Acute pancreatitis
•Evidence of ulcera disease gastrointestinal tract within 3 months, esophageal varices, arterial aneurysm, arteriovenous malformations;
•Neoplasm with high bleeding risk
•Severe liver disease including liver failure, cirrhosis, portal hypertension, acute hepatitis;
•Major trauma or major surgery within 3 months
•Patients at the age of over 80 and under 18 years
•Hemorrhagic stroke or history of stroke of unknown origin;
•Known ischemic stroke or transient ischemic attack in the last 6 months
•Patients on drotrecogin alpha therapy
•Aspirin therapy >650mg q day

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate safety, pharmacokinetics, pharmacodynamics, and clinical efficacy of escalating doses of alteplase in patients with acute lung injury / acute respiratory distress syndrome / severe pneumonia;Secondary Objective: Disease-related-biomarkers, clinical assessment, mortality, safety parameters, PK and PD parameters;Primary end point(s): -PaO2 (partial arterial oxygen pressure)/FiO2 (fraction of inspired oxygen) ratio before and at the end of infusion, at 4, 6, 24, 30, 48, 54, and 72h after the start of the infusion (AUC);Timepoint(s) of evaluation of this end point: Before treatment<br>1,2,4,6,24,30,48,54,72 hours after start of treatment<br>