Cardiac Surgical ProceduresPhase 2TALENNCT07027670

Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery

A Phase 2 study testing 5-Aminolevulinic Acid hydrochloride (5-ALA) and Sodium ferrous citrate (SFC) in people with Cardiac Surgical Procedures and Coronary Artery Bypass, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Surgical Procedures, Coronary Artery Bypass, Aortic Valve Disease
What is being tested?: 5-Aminolevulinic Acid hydrochloride (5-ALA) and Sodium ferrous citrate (SFC)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Feb 2021to 30 Jun 2022
Phase: Phase 2
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

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

About this study

Official title: Pre-operative 5-Aminolevulinic Acid to Activate Haem Oxygenase to Improve Outcomes in Cardiac Surgery: A Dose Finding Study

Read the detailed description

TALEN is a prospective, randomised, double blind, placebo-controlled phase 2 study of 5-ALA-SFC administration in adults undergoing non-emergent cardiac surgery on CPB examining the potential of 5-ALA-SFC to induce haem oxygenase-1 (HO-1) as a novel cardio- and cyto-protective strategy for clinical benefit. 5-ALA is an amino acid found in several foods and a natural endogenous precursor in the synthesis of haem. Oral administration of 5-ALA-SFC has been shown to be safe and to induce a pharmacodynamic effect on the key effector, HO-1. TALEN is designed as a dose-finding trial with sequential dose cohorts, evaluating the safety, tolerability and PD response to 5-ALA-SFC to determine the optimum biological dose for further evaluation.

Conditions: Cardiac Surgical Procedures, Coronary Artery Bypass, Aortic Valve Disease, Mitral Valve Disease
Being tested: 5-Aminolevulinic Acid hydrochloride (5-ALA), Placebo, Sodium ferrous citrate (SFC)
Keywords: heme oxygenase, cardiopulmonary bypass, HO-1, aortic valve replacement, mitral valve surgery, 5-aminolevulinic acid, delta aminolevulinic acid, sodium ferrous citrate
Medical subject headings: Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5-Aminolevulinic Acid hydrochloride (5-ALA)Drug
5-ALA: supplied for oral administration as a dark green, opaque, size 0, hypromellose (HPMC) capsule containing drug alone at a dosage strength of 75mg (58.7mg as 5-ALA). There are no excipients.
PlaceboOther
Supplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing 125mg lactose. The capsule shells are of non-animal origin, and are comprised of HPMC, titanium dioxide, and a copper complex of chlorophyllins.
Sodium ferrous citrate (SFC)Drug
SFC: supplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing drug alone at a dosage strength 118mg (12.5mg as Fe). There are no excipients.

Study groups in NCT07027670
Study group	Role	What they receive
Cohort 1	Experimental	75 mg 5-ALA with 118 mg SFC bd (lowest/starting dose) for three days before surgery (n=8 patients) Receives: Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA); Drug: Sodium ferrous citrate (SFC)
Cohort 2	Experimental	150 mg 5-ALA with 236 mg SFC or bd for three days before surgery (n=8 patients) Receives: Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA); Drug: Sodium ferrous citrate (SFC)
Cohort 3	Experimental	225 mg 5-ALA with 354 mg SFC bd for three days before surgery (n=8 patients) Receives: Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA); Drug: Sodium ferrous citrate (SFC)
Cohort 4	Experimental	300 mg 5-ALA with 472 mg SFC bd (maximum dose) for three days before surgery (n=8 patients) Receives: Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA); Drug: Sodium ferrous citrate (SFC)
Placebo	Placebo comparator	2 patients in each cohort above will be allocated to placebo (n=8 patients in total across the study) Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline HO-1 expression to time of cardiac surgery
Normalised HO-1 expression in peripheral blood
•Safety: Occurrence of adverse events / laboratory safety events defined as dose-limiting toxicity (DLTs)
Measured: Baseline at screening compared to post dose (measured within 12 hours of final dose, before cardiac surgery)
Number of Participants With Dose Limiting Toxicity
Measured: Up to 72 hours post-surgery

Secondary outcomes (3)

Incidence of treatment related emergent AEs [safety and tolerability]
Treatment-related AEs assessed using CTCAE v5.0
Measured: From time of administration of placebo or investigational medicinal product (IMP) (i.e. treatment-emergent AEs, TEAEs) to 72 hours post-operatively
Change from baseline HO activity to time of cardiac surgery
HO enzyme activity
Measured: Baseline at screening compared to post dose (measured within 12 hours of final dose, before cardiac surgery)
Preliminary evaluation of the kinetics of peri-operative myocardial injury
Cardiac troponin area under the curve for 72 hours
Measured: Serial measurements until 72 hours after release of aortic cross clamping

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202130 Jun 2022

First posted18 Jun 2025
Study start1 Feb 2021
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
More trials run by University of OxfordThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Sequential dose escalation cohorts of 10 evaluable patients each (8 on active:2 on placebo) dosed twice daily (bd) with 5-ALA-SFC or placebo for three pre-operative days and once on the day of cardiac surgery. Up to 4 discrete dose levels are anticipated.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07027670
Sponsor's protocol ID: 280513
Acronym: TALEN
Status last verified: Jun 2025
First submitted: 3 May 2022
Last updated: 25 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pre-operative 5-Aminolevulinic Acid to Activate Haem Oxygenase to Improve Outcomes in Cardiac Surgery: A Dose Finding Study
ClinicalTrials.gov ID: NCT07027670
Acronym / sponsor ID: TALEN / 280513
Conditions: Cardiac Surgical Procedures, Coronary Artery Bypass, Aortic Valve Disease, Mitral Valve Disease
Keywords: heme oxygenase, cardiopulmonary bypass, HO-1, aortic valve replacement, mitral valve surgery, 5-aminolevulinic acid, delta aminolevulinic acid, sodium ferrous citrate
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: SBI Pharmaceuticals Co, Ltd., Emerald Clinical Inc.
Study start: 1 Feb 2021 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 18 Jun 2025 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model description: Sequential dose escalation cohorts of 10 evaluable patients each (8 on active:2 on placebo) dosed twice daily (bd) with 5-ALA-SFC or placebo for three pre-operative days and once on the day of cardiac surgery. Up to 4 discrete dose levels are anticipated.

Arm	Type	Receives
Cohort 1	Experimental	Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA), Drug: Sodium ferrous citrate (SFC)75 mg 5-ALA with 118 mg SFC bd (lowest/starting dose) for three days before surgery (n=8 patients)
Cohort 2	Experimental	Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA), Drug: Sodium ferrous citrate (SFC)150 mg 5-ALA with 236 mg SFC or bd for three days before surgery (n=8 patients)
Cohort 3	Experimental	Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA), Drug: Sodium ferrous citrate (SFC)225 mg 5-ALA with 354 mg SFC bd for three days before surgery (n=8 patients)
Cohort 4	Experimental	Drug: 5-Aminolevulinic Acid hydrochloride (5-ALA), Drug: Sodium ferrous citrate (SFC)300 mg 5-ALA with 472 mg SFC bd (maximum dose) for three days before surgery (n=8 patients)
Placebo	Placebo comparator	Other: Placebo2 patients in each cohort above will be allocated to placebo (n=8 patients in total across the study)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

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

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
5-Aminolevulinic Acid hydrochloride (5-ALA)5-ALA: supplied for oral administration as a dark green, opaque, size 0, hypromellose (HPMC) capsule containing drug alone at a dosage strength of 75mg (58.7mg as 5-ALA). There are no excipients.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4
PlaceboSupplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing 125mg lactose. The capsule shells are of non-animal origin, and are comprised of HPMC, titanium dioxide, and a copper complex of chlorophyllins.	Other	Placebo
Sodium ferrous citrate (SFC)SFC: supplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing drug alone at a dosage strength 118mg (12.5mg as Fe). There are no excipients.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4

Primary outcome

Change from baseline HO-1 expression to time of cardiac surgery
Time frame: Baseline at screening compared to post dose (measured within 12 hours of final dose, before cardiac surgery)
Normalised HO-1 expression in peripheral blood •Safety: Occurrence of adverse events / laboratory safety events defined as dose-limiting toxicity (DLTs)
Number of Participants With Dose Limiting Toxicity
Time frame: Up to 72 hours post-surgery

3 secondary outcomes

Incidence of treatment related emergent AEs [safety and tolerability]
Time frame: From time of administration of placebo or investigational medicinal product (IMP) (i.e. treatment-emergent AEs, TEAEs) to 72 hours post-operatively
Change from baseline HO activity to time of cardiac surgery
Time frame: Baseline at screening compared to post dose (measured within 12 hours of final dose, before cardiac surgery)
Preliminary evaluation of the kinetics of peri-operative myocardial injury
Time frame: Serial measurements until 72 hours after release of aortic cross clamping

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 25 Jun 2025.
Individual participant dataSharing planned: No

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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.

Arash Yavari, DPhil MRCP principal investigator

University of Oxford

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 25 Jun 2025. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change from baseline HO-1 expression to time of cardiac surgery (time frame: Baseline at screening compared to post dose (measured within 12 hours of final dose, before cardiac surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07027670.

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 25 Jun 2025.