Efficacy and Safety Study on bIAP (APPIRED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010724
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : November 10, 2009
Alloksys Life Sciences B.V.
Information provided by:
Catharina Ziekenhuis Eindhoven

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Endotoxin-mediated Complications From Cardiopulmonary Bypass Surgery Drug: bIAP Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Official Title: A Randomized, Double-Blind, Placebo Controlled Study of Biap, an Endotoxin Detoxificating Moiety, in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass

Arm Intervention/treatment
Experimental: bIAP
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 Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. To determine the efficacy and safety of bIAP as a prophylaxis against endotoxin-mediated complications from cardiopulmonary bypass surgery

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who are unwilling or unable to be fully evaluated for follow-up.
  2. Patients who undergo CABG for emergency due to complications from percutaneous transluminal coronary angioplasty (PTCA)/ catheterization, unstable angina or ongoing myocardial infarction.
  3. 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).

  4. Patients who show pre-operative infections or who are suspected of having endocarditis or systemic infection.
  5. Patients who refuse to accept medically-indicated blood products.
  6. 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.
  7. 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.
  8. Patients who require pre-operative ventilatory support.
  9. Patients who have renal insufficiency (history of creatinine> 2.0 mg/dL) or chronic renal failure requiring dialysis.
  10. Patients who are planned to receive leukocyte-depletion filtration as part of the bypass circuitry.
  11. Patients with severe neurological deficits (see Appendix I).
  12. Patients who have a recent history of substance or alcohol abuse.
  13. Patients with a diagnosis of idiopathic thrombocytopenia.
  14. 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.
  15. Patients with a history of cancer who have received chemotherapy or radiation therapy within the past 3 months. Patients receiving only adjuvant hormonal therapy are not excluded. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys.
  16. Patients who are scheduled to receive "stress doses" of glucocorticoids (i.e., doses >2 mg/kg/day of methylprednisolone or equivalent) prior to, during or following the operation.
  17. Patients who are vegetarians or vegenists or those patients that may be expected not to be tolerant for bovine proteins.
  18. Patients who have a BMI (body mass index) < 18 or > 30
  19. Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010724

Catharina hospital, dept. of Cardiothoracic Surgery
Eindhoven, Netherlands, 5623EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Alloksys Life Sciences B.V.

Responsible Party: Dr. J.P.A.M. Schonberger, Catharina hospital, department of Cardiothoracic surgery Identifier: NCT01010724     History of Changes
Other Study ID Numbers: APPIRED ALS-001-2005
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases