A Randomised, Double-blind, Placebo-controlled, Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of Different Doses (0.2, 0.6, 2.0, 6.0, and 20.0 μg/hr) of BIWH 3 Administered for 6 Hours in Patients With Chronic Critical Limb Ischaemia (CLI, Fontaine Class III or IV). COINART-1 Trial (First COllateral INto ARTery Trial)
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 7
- Primary Endpoint
- Number of patients with adverse events
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BIWH 3
in escalating doses
Intervention: BIWH 3 (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of patients with adverse events
Time Frame: up to 180 days after drug administration
Number of patients with clinically relevant changes in vital signs (heart rate, blood pressure, body temperature)
Time Frame: baseline, up to 180 days after drug administration
Number of patients with clinically relevant changes in laboratory evaluations
Time Frame: baseline, up to 180 days after drug administration
Number of patients with clinically relevant changes in 12- lead electrocardiogram (ECG)
Time Frame: baseline, up to 180 days after drug administration
Number of patients with clinically relevant changes in markers of inflammation
Time Frame: 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
Time Frame: baseline, up to 180 days after drug administration
Number of patients with changes from baseline in progression of atherosclerosis
Time Frame: day 180
measured by carotid duplex imaging
Number of patients with changes in local disease defined by degree of stenosis
Time Frame: up to 6 months post treatment
assessed by magnetic resonance angiography
Number of patients with changes from baseline in result of cancer screening
Time Frame: day 180
Number of patients developing an antibody response to BIWH 3
Time Frame: baseline, up to 180 days
Secondary Outcomes
- 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)