drugset / Trial / NCT07027670
Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery
Phase 2
Completed
48 enrolled
University of Oxford
Emerald Clinical Inc. · collabSBI Pharmaceuticals Co, Ltd. · collab
RandomizedSequentialQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-02-01
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 75 mg | Oral |
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 150 mg | Oral |
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 225 mg | Oral |
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 300 mg | Oral |
| Subject | Sodium ferrous citrate | Small molecule | 118 mg | Oral |
| Subject | Sodium ferrous citrate | Small molecule | 236 mg | Oral |
| Subject | Sodium ferrous citrate | Small molecule | 354 mg | Oral |
| Subject | Sodium ferrous citrate | Small molecule | 472 mg | Oral |