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Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery

NCT07027670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

  • Cardiac Surgical Procedures
  • Coronary Artery Bypass
  • Aortic Valve Disease
  • Mitral Valve Disease

Interventions

DRUG

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.

OTHER

Placebo

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.

DRUG

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.

Sponsors & Collaborators

  • SBI Pharmaceuticals Co, Ltd.

    collaborator INDUSTRY

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Arash Yavari, DPhil MRCP · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07027670 on ClinicalTrials.gov