InflammationPhase 3APPIRED-IINCT01144611
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
A Phase 3 study testing bIAP bolus and 8h infusion in people with Inflammation, run by Alloksys Life Sciences B.V. at 1 site in Netherlands.
Trial summary
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation
- What is being tested?
- bIAP bolus and 8h infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Dec 2013
- Phase
- Phase 3
- 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
- Male or non-pregnant, non-lactating female patients of any race in the ages of >18 years.
- Patients scheduled for combined aortic valve replacement and CABG surgery.
- Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.
Who cannot join
- Patients who are unwilling or unable to be fully evaluated for follow-up.
- Patients who have base AP levels at > 125 IU/L, or levels < 30 IU/L (ammediol, DEA (diethanolamine) units)
- Patients who show pre-operative infections or who are suspected of 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 > 34.2 µmol/L (> 2.0 mg/dL), ALT (>120) or AST (>135) corresponding to > 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.
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- Patients who require pre-operative ventilatory support.
- Patients who have renal insufficiency (history of creatinine >177mol/L or >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.
- Patients who have a recent history of drug or alcohol abuse.
- Patients with a diagnosis of idiopathic thrombocytopenia.
- 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.
- 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 surgery.
- Patients who are vegetarians or veganists or those patients that may be expected not to be tolerant for bovine proteins.
- Patients who are, in the opinion of the investigator, unsuitable for the study. A well-documented screening log should be present in the clinic.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Ziekenhuis, Dept. CardioThoracic Surgery
Eindhoven, 5623 EJ
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase IIIa Study on bIAP, an Anti-inflammatory Moiety, in Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Grafting
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac surgery: combined aortic valve replacement and coronary artery bypass grafting.
- Conditions
- Inflammation
- Being tested
- bIAP bolus and 8h infusion, placebo bolus and 8h infusion
- Keywords
- valve replacement, CABG, SIRTS, Combined aortic valve replacement and CABG surgery
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bIAP bolus and 8h infusionDrug
intravenous as a bolus of bIAP (bovine intestinal alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery.
placebo bolus and 8h infusionDrug
intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.
| Study group | Role | What they receive |
|---|---|---|
| bIAP | Active comparator | intravenous as a bolus of bIAP (alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery. Receives: Drug: bIAP bolus and 8h infusion |
| placebo | Placebo comparator | intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery. Receives: Drug: placebo bolus and 8h infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-alpha
as indicator of post-surgical inflammatory response
Measured: one day before till 5 days post surgery
Secondary outcomes (1)
incidence of new organ dysfunctions
Measured: till 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alloksys Life Sciences B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- M.Erwin S.H. Tan, Prof.Dr.med., Principal investigator, Catharina Ziekenhuis, Dept. CardioThoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144611
- Sponsor's protocol ID
- ALS-002-2009
- Other IDs
- 2009-010191-19, 2009
- Acronym
- APPIRED-II
- Status last verified
- Jun 2011
- First submitted
- 14 Jun 2010
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase IIIa Study on bIAP, an Anti-inflammatory Moiety, in Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01144611
- Acronym / sponsor ID
- APPIRED-II / ALS-002-2009
- Conditions
- Inflammation
- Keywords
- valve replacement, CABG, SIRTS, Combined aortic valve replacement and CABG surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Alloksys Life Sciences B.V.Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Jun 2010 (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.
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac surgery: combined aortic valve replacement and coronary artery bypass grafting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bIAP | Active comparator | Drug: bIAP bolus and 8h infusionintravenous as a bolus of bIAP (alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery. |
| placebo | Placebo comparator | Drug: placebo bolus and 8h infusionintravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or non-pregnant, non-lactating female patients of any race in the ages of >18 years.
- Patients scheduled for combined aortic valve replacement and CABG surgery.
- Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.
Key exclusion criteria (16 listed)
- Patients who are unwilling or unable to be fully evaluated for follow-up.
- Patients who have base AP levels at > 125 IU/L, or levels < 30 IU/L (ammediol, DEA (diethanolamine) units)
- Patients who show pre-operative infections or who are suspected of 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 > 34.2 µmol/L (> 2.0 mg/dL), ALT (>120) or AST (>135) corresponding to > 3X upper limit of normal.
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 |
|---|---|---|
| bIAP bolus and 8h infusionintravenous as a bolus of bIAP (bovine intestinal alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery. | Drug | bIAP |
| placebo bolus and 8h infusionintravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery. | Drug | placebo |
Primary outcome
TNF-alpha
Time frame: one day before till 5 days post surgery
as indicator of post-surgical inflammatory response
1 secondary outcome
incidence of new organ dysfunctions
Time frame: till 30 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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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.
M.Erwin S.H. Tan, Prof.Dr.med. principal investigator
Catharina Ziekenhuis, Dept. CardioThoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bIAP bolus and 8h infusion in people with Inflammation, run by Alloksys Life Sciences B.V. at 1 site in Netherlands.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TNF-alpha (time frame: one day before till 5 days post surgery). 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 20 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.