Investigation of Safety, Pharmacokinetics and Pharmacodynamics of Different Doses of BIWH 3 in Patients With Chronic Critical Limb Ischaemia
- Registration Number
- NCT02215824
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary aim of this trial was to investigate the safety of a 6 hour intraarterial infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive disease (PAOD) and chronic Critical Limb Ischaemia (Fontaine class III or IV).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIWH 3 BIWH 3 in escalating doses Placebo Placebo -
- Primary Outcome Measures
Name Time Method Number of patients with adverse events up to 180 days after drug administration Number of patients with clinically relevant changes in vital signs (heart rate, blood pressure, body temperature) baseline, up to 180 days after drug administration Number of patients with clinically relevant changes in laboratory evaluations baseline, up to 180 days after drug administration Number of patients with clinically relevant changes in 12- lead electrocardiogram (ECG) baseline, up to 180 days after drug administration Number of patients with clinically relevant changes in markers of inflammation baseline, up to 180 days after drug administration measured by C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR)
Number of patients with clinically relevant changes in ophthalmic examinations baseline, up to 180 days after drug administration Number of patients with changes from baseline in progression of atherosclerosis day 180 measured by carotid duplex imaging
Number of patients with changes in local disease defined by degree of stenosis up to 6 months post treatment assessed by magnetic resonance angiography
Number of patients with changes from baseline in result of cancer screening day 180 Number of patients developing an antibody response to BIWH 3 baseline, up to 180 days
- Secondary Outcome Measures
Name Time Method Changes in transcutaneous oxygen pressure (tcPO2) baseline, up to 180 days after drug administration Changes in lower extremity magnetic resonance angiography (MRA) baseline, up to 180 days after drug administration Changes in ankle brachial or toe brachial index baseline, up to 180 days after drug administration Occurence of amputations up to 180 days after drug administration Progression of ulcer healing up to 180 days after drug administration Changes from baseline on visual analogue scale assessment of pain at rest up to 180 days after drug administration BIWH 3 plasma concentration up to 180 days after drug administration Occurrence of Mac-1 positive staining monocytes up to 180 days after drug administration