An open-label, multi-centre, Phase IIa study to evaluate the safety, tolerability, pharmacodynamic efficacy and dose-related pharmacokinetics of titrated doses of the intravenous thrombin inhibitor TRI 50c in twenty four male and female stable, chronic haemodialysis patients during a maximum of 5 individual haemodialysis sessions.
- Conditions
- Chronic renal failure in patients undergoing chronic haemodialysis.MedDRA version: 6.1Level: PTClassification code 10018367
- Registration Number
- EUCTR2005-000177-22-IT
- Lead Sponsor
- TRIGE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method