Status:
COMPLETED
Effect of Intrapulmonary Recombinant Human Activated Protein C (APC) on Coagulation and Inflammation After Lipopolysaccharide (LPS)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Pneumonia
Lipopolysaccharides
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of patients with severe sepsis. The biological effects of APC are pleiotropic, and can be roughly divided in antico...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male, 18-35 years of age
- No clinically significant findings during physical examination and hematological and biochemical screening
- Normal spirometry and ECG
- Able to communicate well with the investigator and to comply with the requirements of the study
- No medication
- Written informed consent
- No smoking
- Exclusion criteria:
- Known diseases
- A history of smoking within the last six months, or regular consumption of greater than three units of alcohol per day
- Administration of any investigational drug within 30 days of study initiation
- Donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation
- History of enhanced bleeding tendency
- History of heparin-induced thrombocytopenia
- History of serious drug-related reactions, including hypersensitivity
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00943267
Start Date
October 1 2008
End Date
March 1 2011
Last Update
March 16 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Medical Center/ University of Amsterdam
Amsterdam, Netherlands, 1100DD