Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery (NCT07027670) | Clinical Trial Compass
CompletedPhase 2
Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery
United Kingdom48 participantsStarted 2021-02-01
Plain-language summary
TALEN is a prospective randomised double-blind placebo-controlled phase 2 study of 5-Aminolevulinic Acid with Sodium Ferrous Citrate (5-ALA-SFC) in adult patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). TALEN aims to identify the optimal biological dose (OBD) of 5-ALA-SFC.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Scheduled for non-emergent cardiac surgery under CPB (including coronary artery bypass grafting, valve replacement, valve repair or a combination thereof)
* Signed informed consent
* Age ≥18 years
* Able and willing to comply with all study requirements
Exclusion Criteria:
* Female participants who are of childbearing potential who are either unable or unwilling to use highly effective contraception, or who are pregnant or breast feeding
* History of hypersensitivity to 5-ALA, SFC and/or porphyrins
* Acute or chronic types of porphyria
* Known genetic haemochromatosis or clinically significant iron overload
* History of clinically significant photosensitization
* Current long-term (\> 3 months) use of amiodarone
* Concomitant use of hypericin extract (including St John's Wort) or concomitant therapeutic dose oral iron replacement
* Use of other investigational medical product(s) \< 28 days prior to study or 5 half-lives, whichever is longer
* Cardiogenic shock/Low cardiac output syndrome requiring catecholamine infusion and/or mechanical circulatory support prior to induction of anaesthesia for cardiac surgery
* Recent acute myocardial infarction
* Cardiac surgery without cardiopulmonary bypass or induced fibrillating heart surgery
* Inadequate renal or liver function
* Any other condition which, in the opinion of the Investigator, makes the patient unsuitable for or may compromise their participation in the study
What they're measuring
1
Change from baseline HO-1 expression to time of cardiac surgery
Timeframe: Baseline at screening compared to post dose (measured within 12 hours of final dose, before cardiac surgery)
2
Number of Participants With Dose Limiting Toxicity