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Last Updated: December 23, 2024

CLINICAL TRIALS PROFILE FOR TRIHEPTANOIN


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All Clinical Trials for TRIHEPTANOIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00328159 ↗ Nutritional Therapy of the Deficits of Oxidation Mitochondrial of the Fatty Acids Completed Assistance Publique - Hôpitaux de Paris N/A 2006-06-01 Usual dietary therapies of mitochondrial fatty acid oxidation disorders (FAO) are based on 3 strategies: - limitation of lipid intake in the diet; - supplementation of the diet with medium-chain triglycerides (MCT) for patients affected with disorders of long-chain FAO; - some specific supplementations (for example, L-carnitine). These strategies are often ineffective. The aim of the present study is to evaluate new therapeutic ways based on the underlying energetic defect observed in these disorders. The long-term goal is to develop efficient therapies of these disorders.
NCT00947960 ↗ Triheptanoin Treatment Trial for Patients With Adult Polyglucosan Body Disease Completed Ultragenyx Pharmaceutical Inc Phase 2 2009-06-01 The purpose of the study is to determine if triheptanoin is an effective treatment for the symptoms of Adult Polyglucosan Body Disease.
NCT00947960 ↗ Triheptanoin Treatment Trial for Patients With Adult Polyglucosan Body Disease Completed Baylor Research Institute Phase 2 2009-06-01 The purpose of the study is to determine if triheptanoin is an effective treatment for the symptoms of Adult Polyglucosan Body Disease.
NCT00983788 ↗ Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects Completed Groupe Hospitalier Pitie-Salpetriere Phase 2 2009-10-01 The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized, double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers: Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after infusion of stable isotopes (palmitate and glucose tracers).
NCT00983788 ↗ Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects Completed Rigshospitalet, Denmark Phase 2 2009-10-01 The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized, double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers: Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after infusion of stable isotopes (palmitate and glucose tracers).
NCT01379625 ↗ Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder Completed University of Pittsburgh Phase 2 2011-09-01 Humans eat long-chain fat in their diet and use it for energy during exercise and during periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with exercise or illness. They can also develop a heart that does not function properly. These patients are tired and expend less energy than people who do not have a long-chain fatty acid oxidation disorder. However, they can use a supplement oil called medium chain triglyceride or MCT. This study will determine if a new experimental oil called Triheptanoin can decrease the muscle pain and increase the heart function and the amount of energy in patients with long-chain fatty acid oxidation disorders. Funding source - FDA's OOPD
NCT01379625 ↗ Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder Completed Oregon Health and Science University Phase 2 2011-09-01 Humans eat long-chain fat in their diet and use it for energy during exercise and during periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with exercise or illness. They can also develop a heart that does not function properly. These patients are tired and expend less energy than people who do not have a long-chain fatty acid oxidation disorder. However, they can use a supplement oil called medium chain triglyceride or MCT. This study will determine if a new experimental oil called Triheptanoin can decrease the muscle pain and increase the heart function and the amount of energy in patients with long-chain fatty acid oxidation disorders. Funding source - FDA's OOPD
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TRIHEPTANOIN

Condition Name

Condition Name for TRIHEPTANOIN
Intervention Trials
Glucose Transporter Type 1 Deficiency Syndrome 7
Glut1 Deficiency Syndrome 4
GLUT1DS1 3
Very Long-chain acylCoA Dehydrogenase (VLCAD) Deficiency 2
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Condition MeSH

Condition MeSH for TRIHEPTANOIN
Intervention Trials
Syndrome 12
Carbohydrate Metabolism, Inborn Errors 11
Glycogen Storage Disease 5
Metabolic Diseases 5
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Clinical Trial Locations for TRIHEPTANOIN

Trials by Country

Trials by Country for TRIHEPTANOIN
Location Trials
United States 49
France 7
United Kingdom 6
Spain 6
Poland 3
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Trials by US State

Trials by US State for TRIHEPTANOIN
Location Trials
Texas 10
Pennsylvania 7
Florida 5
Washington 3
New York 3
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Clinical Trial Progress for TRIHEPTANOIN

Clinical Trial Phase

Clinical Trial Phase for TRIHEPTANOIN
Clinical Trial Phase Trials
Phase 3 3
Phase 2 18
Phase 1/Phase 2 4
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Clinical Trial Status

Clinical Trial Status for TRIHEPTANOIN
Clinical Trial Phase Trials
Completed 15
Recruiting 5
No longer available 4
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Clinical Trial Sponsors for TRIHEPTANOIN

Sponsor Name

Sponsor Name for TRIHEPTANOIN
Sponsor Trials
Ultragenyx Pharmaceutical Inc 19
University of Texas Southwestern Medical Center 5
Institut National de la Santé Et de la Recherche Médicale, France 4
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Sponsor Type

Sponsor Type for TRIHEPTANOIN
Sponsor Trials
Other 41
Industry 19
NIH 3
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