| sonlicromanol (KH176) / Khondrion |
KH176-301, NCT06451757: KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases |
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| Not yet recruiting | 3 | 150 | NA | Sonlicromanol, KH176, Placebo | Khondrion BV | Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS), Mitochondrial DNA tRNALeu(UUR) m.3243A | 07/27 | 07/27 | | |
2019-000599-40: A study to evaluate the efficacy of KH176 in patients with a genetically confirmed mitochondrial DNA mutation. Patients to be allocated randomly to placebo or investigational drug in different periods; meaning each patient will receive both placebo as well as the investigational drug. Assignment of actual treatment order will be unknown to patient and doctor. |
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| Not yet recruiting | 2 | 27 | Europe, RoW | KH176, KH176, Powder for oral solution | Khondrion B.V., Khondrion B.V. | A genetically confirmed mitochondrial desoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation (including but not limited to MELAS, MIDD and mixed compositions)., Mitochondrial disease, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
2020-000832-23: The KHENEREXT study: An open-label long-term extension study to investigate the long-term safety and effectiveness of KH176 in subjects with a mitochondrial DNA mutation. |
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| Not yet recruiting | 2 | 27 | Europe | Sonlicromanol, KH176, Oral solution | Khondrion B.V., Khondrion B.V. | A genetically confirmed mitochondrial desoxyribonucleic acid (DNA) tRNALeu(UUR) m.3243A>G mutation (including but not limited to MELAS. MIDD and mixed phenotypes., Mitochondrial disease, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
| Completed | 2 | 11 | Europe | Oral administration of 100 mg KH176 twice daily | Khondrion BV, Julius Clinical, ProPharma Group, Certara | Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A | 06/23 | 06/23 | | |
| Suspended | 2 | 24 | Europe | Sonlicromanol, KH176, Placebo | Khondrion BV, Julius Clinical, ProPharma Group, Europees Fonds voor Regionale Ontwikkeling (EFRO), Ardena, Certara | Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A | 12/25 | 12/25 | | |
