Peripheral Arterial DiseasePhase 1COINART-1NCT02215824
Investigation of Safety, Pharmacokinetics and Pharmacodynamics of Different Doses of BIWH 3 in Patients With Chronic Critical Limb Ischaemia
A Phase 1 study testing BIWH 3 in people with Peripheral Arterial Disease, run by Boehringer Ingelheim.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- BIWH 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Oct 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have severe PAOD with Chronic Critical Limb Ischaemia, Fontaine class III (ischaemic pain at rest) or IV (tissue ulceration or gangrene) due to atherosclerotic disease
- Patient must be >= 18 years of age
- Patient must give written informed consent
- Patient must have a life expectancy of at least six months
Who cannot join
- Transient ischaemic attack (TIA), cerebral vascular accident (CVA), myocardial infarction (MI) or episode of unstable angina within the past two months
- Ophthalmologic conditions: moderate to severe nonproliferative retinopathy, proliferative retinopathy, age related maculopathy with choroidal neovascularisation, macular edema, intraocular surgery within the previous 6 months, retinal vein occlusion
- Presence of a clinically significant disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the result of the study or the patient's ability to participate in the study
- ECG results outside of the reference range of clinical relevance including, but not limited to QTcB > 480 msec, PR interval > 240 msec, QRS interval > 140 msec
- History of malignant disease, or a positive result on any of the required cancer screening tests, unless a definitive subsequent evaluation for cancer is determined to be negative
- Patients at increased risk of colorectal cancer, including any of the following (1) colorectal cancer pr polyps in a first-degree relative younger than 60 or in two first-degree relatives of any age, (2) family history of familial adenomatous polyposis or hereditary non-polyposis colon cancer, (3) history of adenomatous polyps, or (4) history of chronic inflammatory bowel disease (chronic ulcerative colitis or Crohn's disease)
Show all 24Show fewer
- Abnormalities greater than two times the upper limit of normal in any of the following laboratory values at Visit 1: alanine-aminotransferase (ALT), aspartate-aminotransferase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase or lactic dehydrogenase (LDH); abnormalities greater than 1.5 times the upper limit of normal of total bilirubin or white blood cell count
- Any concurrent infectious disease requiring treatment
- Severe renal insufficiency (estimated creatinine clearance < 30 mL/min)
- Duffy antigen negative blood type with co-existing moderate to severe renal insufficiency (estimated creatinine clearance < 80 mL/min), to avoid potential risk of significant increase of monocyte chemoattractant protein-1 (MCP-1) levels
- Known glomerulonephritis, even if creatinine clearance is apparently normal
- Thrombocytopenia, i.e. platelet count <100,000 cells/μl at Visit 1
- History of drug or alcohol abuse within the past 2 two years or active drug or alcohol abuse, present alcohol intake more than three drinks per day
- Inability to comply with the protocol
- Treatment with an investigational drug within 30 days or 5 half-lives, whichever is greater before Visit 2
- Use of cilostazol if cilostazol therapy was started within 2 months prior to trial enrollment, or planned initiation of cilostazol therapy during the trial period. Patients who have been on cilostazol for > 2 months prior to enrollment may be enrolled
- Inability to discontinue the intake of coumadin until after completion of the treatment period. Patients who were on coumadin must have an international normalised ratio (INR) < 1.8 at Visit 2
- Previous enrollment in this trial
- Hypersensitivity or allergy to heparin, conventional angiographic contrast dye, or magnetic resonance angiography (MRA) contrast
- Inability to undergo MRA (e.g. heart pacemaker, artificial heart valve, implanted neurostimulator, intrauterine device (IUD), metallic ear implant, implanted port for delivering insulin, or other foreign or implanted or metallic objects such as bullet fragments, metal plates, pins, screws or staples, joint replacement, or penile implant)
- Know HIV-infection
- Unwillingness to take blood products
- Pregnancy (to be excluded by serum and urine beta-human chorionic gonadotropin-test in women of childbearing potential) or breast feeding
- Female of childbearing potential (not 12 months post-menopausal or surgically sterilized) not using one of the following methods of birth control: hormonal contraceptives, oral or injectable/implantable
About this study
Official title: 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)
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).
- Conditions
- Peripheral Arterial Disease
- Being tested
- BIWH 3, Placebo
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIWH 3Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIWH 3 | Experimental | in escalating doses Receives: Drug: BIWH 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 180 days after drug administration
Number of patients with clinically relevant changes in vital signs (heart rate, blood pressure, body temperature)
Measured: baseline, up to 180 days after drug administration
Number of patients with clinically relevant changes in laboratory evaluations
Measured: baseline, up to 180 days after drug administration
Number of patients with clinically relevant changes in 12- lead electrocardiogram (ECG)
Measured: baseline, up to 180 days after drug administration
Number of patients with clinically relevant changes in markers of inflammation
measured by C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR)
Measured: baseline, up to 180 days after drug administration
Number of patients with clinically relevant changes in ophthalmic examinations
Measured: baseline, up to 180 days after drug administration
Number of patients with changes from baseline in progression of atherosclerosis
measured by carotid duplex imaging
Measured: day 180
Number of patients with changes in local disease defined by degree of stenosis
assessed by magnetic resonance angiography
Measured: up to 6 months post treatment
Number of patients with changes from baseline in result of cancer screening
Measured: day 180
Number of patients developing an antibody response to BIWH 3
Measured: baseline, up to 180 days
Secondary outcomes (8)
Changes in transcutaneous oxygen pressure (tcPO2)
Measured: baseline, up to 180 days after drug administration
Changes in lower extremity magnetic resonance angiography (MRA)
Measured: baseline, up to 180 days after drug administration
Changes in ankle brachial or toe brachial index
Measured: baseline, up to 180 days after drug administration
Occurence of amputations
Measured: up to 180 days after drug administration
Progression of ulcer healing
Measured: up to 180 days after drug administration
Changes from baseline on visual analogue scale assessment of pain at rest
Measured: up to 180 days after drug administration
BIWH 3 plasma concentration
Measured: up to 180 days after drug administration
Occurrence of Mac-1 positive staining monocytes
Measured: up to 180 days after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startOct 2002
- Primary completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215824
- Sponsor's protocol ID
- 1181.1
- Acronym
- COINART-1
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02215824
- Acronym / sponsor ID
- COINART-1 / 1181.1
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Oct 2003 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIWH 3 | Experimental | Drug: BIWH 3in escalating doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have severe PAOD with Chronic Critical Limb Ischaemia, Fontaine class III (ischaemic pain at rest) or IV (tissue ulceration or gangrene) due to atherosclerotic disease
- Patient must be >= 18 years of age
- Patient must give written informed consent
- Patient must have a life expectancy of at least six months
Key exclusion criteria (24 listed)
- Transient ischaemic attack (TIA), cerebral vascular accident (CVA), myocardial infarction (MI) or episode of unstable angina within the past two months
- Ophthalmologic conditions: moderate to severe nonproliferative retinopathy, proliferative retinopathy, age related maculopathy with choroidal neovascularisation, macular edema, intraocular surgery within the previous 6 months, retinal vein occlusion
- Presence of a clinically significant disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the result of the study or the patient's ability to participate in the study
- ECG results outside of the reference range of clinical relevance including, but not limited to QTcB > 480 msec, PR interval > 240 msec, QRS interval > 140 msec
- History of malignant disease, or a positive result on any of the required cancer screening tests, unless a definitive subsequent evaluation for cancer is determined to be negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIWH 3 | Drug | BIWH 3 |
| Placebo | Drug | Placebo |
Primary outcome
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
8 secondary outcomes
Changes in transcutaneous oxygen pressure (tcPO2)
Time frame: baseline, up to 180 days after drug administration
Changes in lower extremity magnetic resonance angiography (MRA)
Time frame: baseline, up to 180 days after drug administration
Changes in ankle brachial or toe brachial index
Time frame: baseline, up to 180 days after drug administration
Occurence of amputations
Time frame: up to 180 days after drug administration
Progression of ulcer healing
Time frame: up to 180 days after drug administration
Changes from baseline on visual analogue scale assessment of pain at rest
Time frame: up to 180 days after drug administration
BIWH 3 plasma concentration
Time frame: up to 180 days after drug administration
Occurrence of Mac-1 positive staining monocytes
Time frame: up to 180 days after drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIWH 3 in people with Peripheral Arterial Disease, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: up to 180 days after drug administration). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.