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Metabolism, Inborn Errors clinical trials

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NCT ID: NCT01289938 Terminated - Clinical trials for Drug Metabolism, Poor, CYP2D6-RELATED

Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

MalD
Start date: July 2009
Phase: Phase 1
Study type: Interventional

Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6

NCT ID: NCT01205867 Completed - Clinical trials for Butyrylcholinesterase Deficiency

Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects

Start date: September 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.

NCT ID: NCT01141075 Terminated - Clinical trials for Amino Acid Metabolism, Inborn Errors

Ataluren for Nonsense Mutation Methylmalonic Acidemia

Start date: July 19, 2010
Phase: Phase 2
Study type: Interventional

Methylmalonic acidemia (MMA) is a rare genetic disorder caused by mutations in the gene for mitochondrial enzyme methylmalonyl-CoA mutase (MCM) or in one of the genes for adenosylcobalamin (AdoCbl). Lack of these proteins causes toxic elevations of methylmalonic acid (MMacid) in blood, urine, and other tissues. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of the disease in approximately 5% to 20% of participants with mutations in the MCM gene, and approximately 20% to >50% of participants with mutations in one of the AdoCbl genes. Ataluren is an orally delivered, investigational drug that acts to overcome the effects of the premature stop codon, potentially enabling the production of functional MCM/AdoCbl. This study is a Phase 2a trial evaluating the safety and activity of ataluren in participants with MMA due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely decrease MMacid levels.

NCT ID: NCT01049854 Completed - Lymphoma Clinical Trials

CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant

Start date: September 2011
Phase: Phase 2
Study type: Interventional

CD34+ stem cell selection in children, adolescents and young adults receiving partially matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral blood stem cell transplant will be safe and well tolerated and be associated with a low incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).

NCT ID: NCT01003912 Withdrawn - Clinical trials for Inborn Errors of Metabolism

Fetal Umbilical Cord Blood (UCB) Transplant for Lysosomal Storage Diseases

IUHST-001
Start date: October 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if it is safe to administer unrelated umbilical cord blood to pregnant women in their first trimester of pregnancy with a fetus that has a known diagnosis of certain lysosomal storage diseases. These diseases are known to cause severe and irreversible neurological disability in early infancy and which are lethal in childhood.

NCT ID: NCT00983788 Completed - Clinical trials for Very Long Chain Acyl Coa Dehydrogenase Deficiency

Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects

Bezafibrate
Start date: October 2009
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT00843921 Active, not recruiting - Clinical trials for Inborn Errors of Metabolism

N-Carbamylglutamate (Carbaglu) In The Treatment Of Hyperammonemia

Start date: August 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study is based on the hypothesis that a new drug N-carbamylglutamate (Carbaglu®) will enhance the ability of the liver to dispose of toxic ammonia which accumulates in several metabolic diseases including urea cycle disorders and organic acid disorders.

NCT ID: NCT00841984 Terminated - Clinical trials for Neurological Diseases

In Vitro NMR Spectroscopy in Neurological Diseases

SPECMET
Start date: July 2006
Phase: N/A
Study type: Observational

The search for metabolic abnormalities in patients with neurological disorders represents an important challenge 1) to identify new potentially treatable inherited metabolic diseases, and 2) to identify biomarkers or new treatments in more common neurodegenerative or neurogenetic disorders. This approach is currently limited by the fact that techniques aiming at identifying abnormal metabolites in human fluids (metabolomics) only detect subsets of molecules and that no general assays is available to detect abnormalities in the metabolism of complex molecules that takes place within cell organelles. As a consequence, only limited parts of the metabolism can be studied simultaneously. The aim of this study is to evaluate whether NRM spectroscopy of body fluids (urines, cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with complex neurological diseases.

NCT ID: NCT00744692 Completed - Thalassemia Clinical Trials

Reduced Intensity Conditioning for Umbilical Cord Blood Transplant in Pediatric Patients With Non-Malignant Disorders

Start date: October 2008
Phase: Phase 1
Study type: Interventional

The primary objective is to determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor chimerism at 180 days) following reduced intensity conditioning (RIC) regimens in pediatric patients < 21 years receiving cord blood transplantation for non-malignant disorders.

NCT ID: NCT00694109 Completed - Clinical trials for Hypercholesterolemia

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

Start date: April 2008
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.