Efficacy and Safety Study on bIAP

NCT01010724 | Completed Phase 3 DMC

• 1 other identifier: APPIRED ALS-001-2005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study drug bIAP, or matching placebo, will be administered as a bolus of 1000 Units bIAP or matching placebo prior to anaesthesia (T = -15 minutes), directly followed by intravenous continuous infusion of about 5.6 units per kg bodyweight/hr at pump rate 4 ml/hr for approximately 36 hrs (total 200 IU/kg/36 hrs) into each of a total of 50 patients scheduled for coronary artery bypass graft surgery (CABG). Risk of surgical complications and mortality due to co-morbid conditions will be collected and the EuroSCORE will be used to screen patients prior to surgery.

Conditions

Coronary Artery Disease; Endotoxin-mediated Complications From Cardiopulmonary Bypass Surgery

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy and safety of bIAP as a prophylaxis against endotoxin-mediated complications from cardiopulmonary bypass surgery

Study Arms (2)

bIAP

EXPERIMENTAL

Dosage 200 IU bIAP/kg: 1000 IU prior to anaesthesia administered as a bolus followed by intravenous continuous infusion of 5,6 IU/kg/hr for approximately 36 hours.

Drug: bIAP

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

bIAP DRUG

bIAP

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female patients of any race in the ages of \>18 years. Women must be of non-childbearing potential.
• Patients scheduled for coronary artery bypass surgery with CPB.
• Patients must have a EuroSCORE (Appendix I) of \>2 and \<6.
• Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.

You may not qualify if:

• Patients who are unwilling or unable to be fully evaluated for follow-up.
• Patients who undergo CABG for emergency due to complications from percutaneous transluminal coronary angioplasty (PTCA)/ catheterization, unstable angina or ongoing myocardial infarction.
• Patients who have base alkaline phosphatase levels at \> 100 IU/l (70 IU/L as mean concentration) levels, or levels \< 30 IUnits/L (ammediol, DEA units)
• (values base levels in glycine units at pH9.6 and 25 C are respectively \>40 and \< 12 IU/L).
• Patients who show pre-operative infections or who are suspected of having endocarditis or systemic infection.
• Patients who refuse to accept medically-indicated blood products.
• Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin \> 2.0 mg/dL, ALT or AST\> 3X upper limit of normal.
• Patients who received investigational drugs in the 30 days prior to study drug administration, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated.
• Patients who require pre-operative ventilatory support.
• Patients who have renal insufficiency (history of creatinine\> 2.0 mg/dL) or chronic renal failure requiring dialysis.
• Patients who are planned to receive leukocyte-depletion filtration as part of the bypass circuitry.
• Patients with severe neurological deficits (see Appendix I).
• Patients who have a recent history of substance or alcohol abuse.
• Patients with a diagnosis of idiopathic thrombocytopenia.
• Concomitant surgical procedures (i.e., not included in Appendix VI) anticipated to require greater than 2.5 hours time "on-pump" or patients for whom surgery other than coronary artery bypass surgery is planned during the 30-day study period.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Alloksys Life Sciences B.V.: collaborator

Study Sites (1)

Catharina hospital, dept. of Cardiothoracic Surgery

Eindhoven, 5623EJ, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

2-(3',4'-dihydroxyphenyl-1-azo)benzimidazole

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 10, 2009
• Last Updated: November 10, 2009

Record last verified: 2009-11

Locations

NL (1)